Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients
- Conditions
- Testicular Cancer
- Interventions
- Other: Observation of testicular cancer patients
- Registration Number
- NCT06389409
- Lead Sponsor
- IRCCS San Raffaele
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 3000
- 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
- subjects < 18 years
- presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with testicular cancer Observation of testicular cancer patients * 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
- Primary Outcome Measures
Name Time Method Clinical data Baseline Collection of clinical data
Testicular objective examination Baseline Number and size (via Prader orchidometer) of the testicles
Adjuvant therapy Baseline Which type of adjuvant therapy carried out (chemotherapy - radiotherapy - retroperitoneal lymphadenectomy)
lactate dehydrogenase Follow up after 6 months from baseline Oncological follow-up through enzymatic value
Testicular objective examination - nodules Baseline Evaluation presence of nodules
Testicular objective examination - hydrocele Baseline Evaluation presence of hydrocele
α-feto protein Follow up after 6 months from baseline Oncological follow-up through enzymatic value
Testicular objective examination - cysts Baseline Evaluation presence of cysts
Testicular objective examination - varicocele Baseline Evaluation presence of varicocele
β human Chorionic Gonadotropin Follow up after 6 months from baseline Oncological follow-up through hormonal value
carcinoembryonic antigen Follow up after 6 months from baseline Oncological follow-up through hormonal value
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IRCCS Ospedale San Raffaele
🇮🇹Milan, Lombardy, Italy