Covid19, Genito Urinary Cancer
Conditions
Keywords
Urothelial cancer, prostate cancer, Germ line cancer, Kidney cancer, COVID-19
Brief summary
The identification of patients with genitourinary tumors who suffer from the infection by the Serious Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2) virus can represent multiple benefits both for themselves and for health professionals and the health system itself. We would be able to know more precisely the clinical evolution of these type of patient, to know their prognosis and being capable to select the most appropriate treatment modality for future pandemics. SOGUG-COVID is an observational prospective-retrospective trial purely epidemiological, that aims to describe the population with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) infected by COrona VIrus Disease 19 (COVID-19) treated in Spanish hospitals, learn about the clinical presentation, therapeutic evolution and prognosis of said intercurrent infectious process, as well as its possible relationship with different clinical and therapeutic factors.
Detailed description
The study will be carried out in Spanish hospitals, with principal investigators belonging to the medical oncology services of the SOGUG group (Spanish Group of Genitourinary Oncology), who will act as promoter. Once the patients have been selected, the variables of interest will be collected and studied. The main variables to record will be: 1. Patient characteristics 2. Hospital center where the patient is recruited 3. Pathological history: Concomitant pathology Usual drug treatment 4. Tumor pathology: Tumor type, histology, and stage (initial and at diagnosis of infection) Cancer diagnosis date Active cancer treatment or follow-up Participation in clinical trial Type of treatment most recently received for the infection (Surgery; Radiotherapy; Chemotherapy, Immunotherapy ...) Treatment lines, initiation and last dose received of the most recent most recent cancer treatment 5. COVID-19 infection: Confirmation date of COVID-19 infection PCR (Polymerase Chain Reaction) diagnostic test Immunoglobulin G (IgG) or Immunoglobulin M (IgM) serological diagnostic test Present symptoms, analytical alterations, thrombosis associated with COVID-19 infection, complications of infection Date of onset and disappearance of symptoms Days of fever and cough Radiological examination at the time of greatest severity Treatments received for COVID-19 Status upon discharge Date of discharge / exitus Negative presence of virus by PCR and PCR date 6. For patients who are receiving or have received immunotherapy treatments, additional information will be collected: Immunotherapy treatment line and type Start / end date and last dose previous infection of the treatment with immunotherapy Adverse effects 7. Prospective follow-up data (6 months from patient inclusion): Date of start or restart of cancer treatment after infection Change / suspension of cancer treatment after COVID-19 Date of surgery in neoadjuvant patients Recurrence of COVID-19 Best response obtained Date of progression to cancer treatment Current status and date of last contact The study will use the data obtained from the patient's medical history, with no plans to use other sources. The assignment of a patient to a specific therapeutic strategy has already been decided in advance by the usual clinical practice of medicine; The decision to prescribe a specific treatment is clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, whether diagnostic or follow-up, that is not the usual clinical practice. Epidemiological methods will be used to analyze the collected data.
Interventions
None listed
Sponsors
Spanish Oncology Genito-Urinary Group
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old. * Diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ). * COVID-19 infection prior to cancer treatment, during treatment, or after treatment. * The COVID-19 infection must be confirmed by PCR or serology, regardless of whether or not the patient requires hospitalization for the infection, additionally, a clinical and / or radiological determination must be available in those patients who present symptoms.
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Age at Baseline | Baseline, at the time of inclusion | Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals, know the clinical presentation: Spcifically here we reported the Age |
| Frequency of Complications of COVID-19 Intercurrent Infection | Through study completion, average 1 year | Percentage of patients with complications associated to COVID-19 infection (classified by type and severity) |
| Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment | Through study completion, average 1 year | To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received. |
| Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment | Through study completion, average 1 year | To evaluate in patients with Genitourinary Cancer the impact of androgen deprivation therapy (ADT) and new antiandrogenic agents (NAH) with or without corticosteroids on the infection COVID-19 as mean of frequency in complications of COVID-19 infection classified by type and severity |
| Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy) | Through study completion, average 1 year | To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received. |
| Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed) | To specifically assess the impact of COVID-19 infection on the toxicity of immunotherapy treatment (mainly pneumonitis) and the impact of immunotherapy on the evolution of the infectious picture in patients with tumors of genitourinary origin. three different scenarios: during treatment, after treatment and in patients who receive treatment after the infection has passed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asymptomatic Rate in Testicular Cancer | Through study completion, average 1 year | Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections |
| Frequency of Delays/Modifications on Cancer Treatment Schedule | Through study completion, average 1 year | delays / modifications in cancer follow-up or treatment regimens. |
| COVID-19 Mortality Rate in Patients With Genitourinary Cancer | Through study completion, average 1 year | To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge. |
| Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19 | From start of treatment until progression or death, up to 130 months | It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology. For the calculation of overall survival, it is taken from the date of cancer diagnosis to the date of death (at any time, not only in a prospective part). |
| Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection | From start of treatment until progression or death, up to 130 months | It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology. PROGRESSION FREE SURVIVAL (FIRST LINE IN METASTATIC OR ADVANCED SETTING) The date of treatment start (treatment ongoing at the moment of COVID infection) is taken as the start date of follow-up. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed. |
| COVID-19 Complication Rate in Patients With Genitourinary Cancer | Through study completion, average 1 year | Evaluate the rate (percentage) of complications that have required hospital admission and / or ICU treatment. Complications will be classified by type and severity and represented as percentage of patients presenting them. |
| Asymptomatic Rate | Through study completion, average 1 year | Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections. |
| Asymptomatic Rate in Renal Cancer | Through study completion, average 1 year | Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections. |
| Asymptomatic Rate in Urothelial Cancer | Through study completion, average 1 year | Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections. |
| Asymptomatic Rate in Prostate Cancer | Through study completion, average 1 year | Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment. | 408 |
| Total | 408 |
Baseline characteristics
| Characteristic | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Age, Continuous | 70 years |
| Anticancer treatment status at SARS-CoV-2 infection Active | 238 Participants |
| Anticancer treatment status at SARS-CoV-2 infection Follow-up | 170 Participants |
| Anticancer treatment type at SARS-CoV-2 infection Adjuvant | 10 Participants |
| Anticancer treatment type at SARS-CoV-2 infection Metastatic / palliative | 219 Participants |
| Anticancer treatment type at SARS-CoV-2 infection Neo-adjuvant | 8 Participants |
| Anticancer treatment type at SARS-CoV-2 infection UK | 1 Participants |
| Cancer type Kidney | 90 Participants |
| Cancer type Penile | 1 Participants |
| Cancer type Prostate | 166 Participants |
| Cancer type Testicular | 23 Participants |
| Cancer type Urothelial | 128 Participants |
| Clinical cancer stage at cancer diagnosis; 0 | 2 Participants |
| Clinical cancer stage at cancer diagnosis; I | 54 Participants |
| Clinical cancer stage at cancer diagnosis; II | 64 Participants |
| Clinical cancer stage at cancer diagnosis; III | 90 Participants |
| Clinical cancer stage at cancer diagnosis; IV | 166 Participants |
| Clinical cancer stage at cancer diagnosis; UK | 32 Participants |
| Clinical cancer stage at SARS-CoV-2 infection I | 19 Participants |
| Clinical cancer stage at SARS-CoV-2 infection II | 22 Participants |
| Clinical cancer stage at SARS-CoV-2 infection III | 29 Participants |
| Clinical cancer stage at SARS-CoV-2 infection IV | 291 Participants |
| Clinical cancer stage at SARS-CoV-2 infection o | 24 Participants |
| Clinical cancer stage at SARS-CoV-2 infection UK | 23 Participants |
| Comorbities Cardiopathy | 79 Participants |
| Comorbities COPD / Asma | 57 Participants |
| Comorbities Diabetes | 92 Participants |
| Comorbities Hepatopathy | 19 Participants |
| Comorbities Hypertension | 224 Participants |
| Comorbities Nephropathy | 53 Participants |
| Comorbities None | 121 Participants |
| Histopathological grade at SARS-CoV-2 infection Moderately differentiated | 61 Participants |
| Histopathological grade at SARS-CoV-2 infection Poorly differentiated | 136 Participants |
| Histopathological grade at SARS-CoV-2 infection UK | 180 Participants |
| Histopathological grade at SARS-CoV-2 infection Well differentiated | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 408 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 357 Participants |
| Smoking status Ever | 231 Participants |
| Smoking status Never | 136 Participants |
| Smoking status UK | 41 Participants |
| Time from cancer diagnosis to SARS-CoV-2 infection | 32 months |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 152 / 408 |
| other Total, other adverse events | 22 / 87 |
| serious Total, serious adverse events | 0 / 87 |
Outcome results
Primary
Age at Baseline
Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals, know the clinical presentation: Spcifically here we reported the Age
Time frame: Baseline, at the time of inclusion
Population: Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Age at Baseline | 70 years |
Primary
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
To specifically assess the impact of COVID-19 infection on the toxicity of immunotherapy treatment (mainly pneumonitis) and the impact of immunotherapy on the evolution of the infectious picture in patients with tumors of genitourinary origin. three different scenarios: during treatment, after treatment and in patients who receive treatment after the infection has passed.
Time frame: Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Arthritis G1 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Arthritis G3 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Colitis G1 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Colitis G2 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Colitis G3 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Hepatitis G2 | 3 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Hepatitis G3 | 3 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Hepatitis G4 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Hypophysitis G2 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Nephritis G1 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Nephritis G2 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Nephritis G3 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Nephritis G4 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Pneumonitis G2 | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Thyroiditis G1 | 2 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity) | Thyroiditis G2 | 2 Participants |
Primary
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
To evaluate in patients with Genitourinary Cancer the impact of androgen deprivation therapy (ADT) and new antiandrogenic agents (NAH) with or without corticosteroids on the infection COVID-19 as mean of frequency in complications of COVID-19 infection classified by type and severity
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment | Corticosteroid treatment/ no Pneumonia | 59 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment | Corticosteroid treatment/ si Pneumonia | 55 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment | No Corticosteroid treatment/ no Pneumonia | 173 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment | No Corticosteroid treatment/ si Pneumonia | 120 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment | UK | 1 Participants |
Primary
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment
To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment | Immunotherapy treatment/no Pneumonia | 51 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment | Immunotherapy treatment/ Pneumonia | 36 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment | No Immunotherapy treatment/no Pneumonia | 181 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment | No Immunotherapy treatment/Pneumonia | 140 Participants |
Primary
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy) | Immunotherapy treatment /no complications | 45 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy) | Immunotherapy treatment /admissions | 31 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy) | Immunotherapy treatment /Death secondary to infection | 11 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy) | No Immunotherapy treatment /no complications | 146 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy) | No Immunotherapy treatment /admissions | 113 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy) | No Immunotherapy treatment /Death secondary to infection | 62 Participants |
Primary
Frequency of Complications of COVID-19 Intercurrent Infection
Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)
Time frame: Through study completion, average 1 year
Population: Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Intercurrent Infection | Death secondary to infectioninfection | 73 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Intercurrent Infection | ICU admission due to need of symptom control | 5 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Intercurrent Infection | Hospital admission due to need of symptom control | 136 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Intercurrent Infection | Need for mechanical ventilation | 3 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Complications of COVID-19 Intercurrent Infection | No complications. Common infection at home | 191 Participants |
Secondary
Asymptomatic Rate
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate | symptomatic | 308 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate | Asymptomatic | 100 Participants |
Secondary
Asymptomatic Rate in Prostate Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate in Prostate Cancer | Asymptomatic | 33 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate in Prostate Cancer | Symptomatic | 133 Participants |
Secondary
Asymptomatic Rate in Renal Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate in Renal Cancer | Asymptomatic | 27 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate in Renal Cancer | Symptomatic | 63 Participants |
Secondary
Asymptomatic Rate in Testicular Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate in Testicular Cancer | asymptomatic | 6 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate in Testicular Cancer | symptomatic | 15 Participants |
Secondary
Asymptomatic Rate in Urothelial Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate in Urothelial Cancer | Asymptomatic | 32 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Asymptomatic Rate in Urothelial Cancer | Symptomatic | 96 Participants |
Secondary
COVID-19 Complication Rate in Patients With Genitourinary Cancer
Evaluate the rate (percentage) of complications that have required hospital admission and / or ICU treatment. Complications will be classified by type and severity and represented as percentage of patients presenting them.
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | COVID-19 Complication Rate in Patients With Genitourinary Cancer | Death secondary to infection | 73 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | COVID-19 Complication Rate in Patients With Genitourinary Cancer | ICU admission due to need of symptom control | 5 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | COVID-19 Complication Rate in Patients With Genitourinary Cancer | Hospital admission due to need of symptom control | 136 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | COVID-19 Complication Rate in Patients With Genitourinary Cancer | Need for mechanical ventilation | 3 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | COVID-19 Complication Rate in Patients With Genitourinary Cancer | No complications. Common infection at home | 191 Participants |
Secondary
COVID-19 Mortality Rate in Patients With Genitourinary Cancer
To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.
Time frame: Through study completion, average 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | COVID-19 Mortality Rate in Patients With Genitourinary Cancer | Alive | 137 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | COVID-19 Mortality Rate in Patients With Genitourinary Cancer | Dead | 80 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | COVID-19 Mortality Rate in Patients With Genitourinary Cancer | NA | 191 Participants |
Secondary
Frequency of Delays/Modifications on Cancer Treatment Schedule
delays / modifications in cancer follow-up or treatment regimens.
Time frame: Through study completion, average 1 year
Population: Patients with genitourinary tumor presenting Covid-19 infection with prospective part who start/restart treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | Start Treatment after COVID-19 | 20 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | Restart Treatment after COVID-19 | 146 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | With treatment after COVID-19 without specifying start/restart | 6 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | Without oncology treatment after COVID-19 (reported) | 154 Participants |
Secondary
Frequency of Delays/Modifications on Cancer Treatment Schedule
delays / modifications in cancer follow-up or treatment regimens.
Time frame: Through study completion, average 1 year
Population: Patients with genitourinary tumor presenting Covid-19 infection with prospective part witn treatment modifications
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | Dose | 1 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | Change in administration schedule | 15 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | Temporary suspension of treatment | 22 Participants |
Secondary
Frequency of Delays/Modifications on Cancer Treatment Schedule
delays / modifications in cancer follow-up or treatment regimens.
Time frame: Through study completion, average 1 year
Population: Patients with genitourinary tumor presenting Covid-19 infection with prospective part
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | Yes Treatment modification (prospective visit) | 38 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | No Treatment modification (prospective visit) | 108 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | New treatment o no treatment start date | 24 Participants |
| Genitourinary Cancer Patients That Suffered COVID-19 | Frequency of Delays/Modifications on Cancer Treatment Schedule | NA/UK | 156 Participants |
Secondary
Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19
It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology. For the calculation of overall survival, it is taken from the date of cancer diagnosis to the date of death (at any time, not only in a prospective part).
Time frame: From start of treatment until progression or death, up to 130 months
Population: Patients with genitourinary tumor presenting Covid-19 infection with prospective part
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19 | Renal | 18.36 years |
| Genitourinary Cancer Patients That Suffered COVID-19 | Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19 | Urothelial | 7.03 years |
| Genitourinary Cancer Patients That Suffered COVID-19 | Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19 | Prostate | 11.49 years |
| Genitourinary Cancer Patients That Suffered COVID-19 | Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19 | Testicular | 24.37 years |
Secondary
Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection
It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology. PROGRESSION FREE SURVIVAL (FIRST LINE IN METASTATIC OR ADVANCED SETTING) The date of treatment start (treatment ongoing at the moment of COVID infection) is taken as the start date of follow-up. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.
Time frame: From start of treatment until progression or death, up to 130 months
Population: Patients with genitourinary tumors that suffered COVID-19. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection | Renal | 93.26 months |
| Genitourinary Cancer Patients That Suffered COVID-19 | Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection | Urothelial | 80.13 months |
| Genitourinary Cancer Patients That Suffered COVID-19 | Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection | Prostate | 121.94 months |