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Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients

Observational Study on the Quality of Life and Functional/Oncological Outcome of Patients Undergoing Surgery for Testicular Removal and/or Removal of Retro-peritoneal Lymph Nodes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06389409
Enrollment
3000
Registered
2024-04-29
Start date
2010-08-24
Completion date
2040-08-31
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular Cancer

Keywords

testicular cancer

Brief summary

The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition. From this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient.

Detailed description

Testicular cancer constitutes 1% to 1.5% of male tumors, 5% of urological tumors. In the Western society to which we belong, the incidence is between 3 and 6 new cases per 100,000 inhabitants per year. In particular, this incidence has recorded continuous growth over the last thirty years. Different histologies of this disease are known, with a clear prevalence of germ cell tumors (90-95%). From these general epidemiological coordinates it can be deduced that this pathology could affects a young segment of the population; It must be underlined that a pathology is peculiar due to the impact it has on the affected individual, who must be treated not only from an oncological point of view but also with regards to the sexual, reproductive and psychological-relational aspects. Such complexity requires a systematic and detailed approach to examine all aspects. The creation of this database let to have a follow up above all an extension over time that is not present in the literature, especially towards the functional aspects of this condition. The database will represent a resource for future research.

Interventions

OTHERObservation of testicular cancer patients

Collection of clinical data of all patients suffering from neoplastic testicular pathology undergoing surgery

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

Inclusion criteria

* subjects suffering from suspected neoplastic testicular pathology candidates for testicle removal surgery * patients suffering from neoplastic testicular pathology requiring removal of the retroperitoneal lymph nodes * subjects \> 18 years old * subjects with at least elementary education * signature of informed consent

Exclusion criteria

* subjects \< 18 years * presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol

Design outcomes

Primary

MeasureTime frameDescription
Clinical dataBaselineCollection of clinical data
Adjuvant therapyBaselineWhich type of adjuvant therapy carried out (chemotherapy - radiotherapy - retroperitoneal lymphadenectomy)
lactate dehydrogenaseFollow up after 6 months from baselineOncological follow-up through enzymatic value
Testicular objective examinationBaselineNumber and size (via Prader orchidometer) of the testicles
Testicular objective examination - cystsBaselineEvaluation presence of cysts
Testicular objective examination - nodulesBaselineEvaluation presence of nodules
Testicular objective examination - varicoceleBaselineEvaluation presence of varicocele
Testicular objective examination - hydroceleBaselineEvaluation presence of hydrocele
α-feto proteinFollow up after 6 months from baselineOncological follow-up through enzymatic value
β human Chorionic GonadotropinFollow up after 6 months from baselineOncological follow-up through hormonal value
carcinoembryonic antigenFollow up after 6 months from baselineOncological follow-up through hormonal value

Countries

Italy

Contacts

Primary ContactAndrea Salonia, MD
salonia.andrea@hsr.it+390226435661
Backup ContactAlessia d'Arma, PhD
darma.alessia@hsr.it02 2643 5506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026