Cancer, Covid19, Tumor
Conditions
Keywords
Covid19, Cancer
Brief summary
Cancer patients are considered vulnerable to COVID-19 infection. During the pandemic, cancer patients may need to continue their regular treatment of chemotherapy and / or radiotherapy and therefore must visit a hospital unit. As such, they may be at risk for SARS-CoV-2 infection by means of close contact to other patients and health care workers. Hospitals may implement policies to identify symptomatic subjects and limit their access to the chemotherapy / radiotherapy unit. However, asymptomatic COVID-19 positive patients may escape these filters and potentially be contagious to other patients and their health-related workers that care for other several patients. Therefore, there is a real risk of an outbreak that affects a particularly fragile patient population. Patients and their doctors need to know what is the risk associated to visiting a chemotherapy unit in order to decide if the risk outweighs the benefits of cancer treatment in their particular case. To date, this risk is unknown. The study will test patients and health care workers for COVID-19 infection during the peak of the pandemic in a chemotherapy unit in Mexico in order to determine this risk.
Detailed description
In this is prospective cohort, patients with solid tumors and healthcare workers of the chemotherapy and radiotherapy unit at our center will be followed with a daily digital survey and optionally with biweekly PCR tests for SARS-CoV-2. People with symptoms and / or with a positive PCR test for SARS-CoV-2 will be notified and recommendations according to clinical state will be emitted. Hypothesis: COVID-19 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy will be less than 5% during the pandemic period.
Interventions
None listed
Sponsors
Instituto Nacional de Medicina Genomica
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with solid tumors receiving active oncological treatment (chemotherapy, or radiotherapy or biologic therapy) at our center. * Age: no limit * Gender: men and women. * Health-related worker treating patients with solid tumors at the chemotherapy and radiotherapy unit at our center. * People who sign an informed consent.
Exclusion criteria
* Patients with an hematologic cancer. * Patients with cancer under surveillance or without active oncological treatment, or receiving treatment in another center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 infection rate in patients with solid tumors. | From June 2020 to September 2020. | Determination of SARS-CoV-2 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy during the pandemic period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Integration of a cohort of patients with solid tumors receiving oncological treatment. | 4 months | Identification of patients with solid tumors receiving chemotherapy and / or radiotherapy in our center during the COVID-19 pandemic to get informed consent. |
| SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms. | 4 months | To determine the SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms through a PCR test for SARS-CoV-2. |
| SARS-CoV-2 infection rate in asymptomatic patients with solid tumors. | 4 months | To determine the SARS-CoV-2 infection rate in asymptomatic patients with solid tumors through a biweekly PCR test for SARS-CoV-2. |
| Determination of clinical features and outcomes of cancer patients infected with SARS-CoV-2 . | 4 months | Determination of demographics, clinical and outcomes of cancer patients infected with SARS-CoV-2. |
| Integration of a cohort of healthcare workers. | 4 months | Identification of healthcare workers that treat patients with solid tumors in the chemotherapy and radiotherapy unit at our center to get informed consent. |
| Daily digital follow-up of new-onset respiratory symptoms in the cohort of patients with solid tumors. | 4 months | To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 among the cohort of patients with solid tumors through a daily digital survey. |
| SARS-CoV-2 infection rate in the cohort of health-related workers and respiratory symptoms. | 4 months | To determine the SARS-CoV-2 infection rate in the cohort of healthcare workers with respiratory symptoms through a PCR test for SARS-CoV-2. |
| SARS-CoV-2 infection rate in asymptomatic healthcare workers. | 4 months | To determine the SARS-CoV-2 infection rate in asymptomatic healthcare workers through a biweekly PCR test for SARS-CoV-2. |
| Determination of past infection rate in asymtomatic people through SARS-CoV-2 IgG antibodies detection. | 4 months | Determination of past infection rate in both cohorts (patients with solid tumors and health-related workers) through IgG antibodies detection at the beginning and at the end of the trial. |
| Register of oncological patients with solid tumors diagnosed with COVID-19. | 4 months | To create a register of oncological patients with solid tumors diagnosed with COVID-19. |
| Daily digital follow-up of new-onset respiratory symptoms in the cohort of healthcare workers. | 4 months | To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 between the cohort of healthcare workers through a daily digital survey. |
Countries
Mexico
Outcome results
None listed