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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06142500
Other study ID # West KOaSt
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date September 21, 2026

Study information

Verified date November 2023
Source IRCCS San Raffaele
Contact Andrea Salonia, MD
Phone +390226435661
Email salonia.andrea@hsr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The project aims to identify the possible risk factors regarding the onset of the disease and to evaluate genes and gene modifications responsible for the onset od testicular cancer.


Description:

Testicular tumor represents a relatively rare disease that hit young-adults men. It represents 1% of all male cancers and 5% of all urological male tumors. Its incidence grow year by year. In the field of the oncological research, the lack of knowledge about genes related to this disease represent a very relevant clinical question. For this reason this project aims to collect biological samples of saliva from testicular cancer patients and from their first-degree family members; demographic-clinical variables will be also collected in order to draft a comprehensive panel of genes and gene modifications related to the testicular cancer, combining this survey with a very detailed description of this cohort of patient in terms of clinical features and quality of life.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4500
Est. completion date September 21, 2026
Est. primary completion date September 21, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Male testicular cancer patients with an age > 18 and < 90 - First degree family members of Male testicular cancer patients with an age > 18 and < 90 - Ability to read and sign the informed consent - Diagnosis of testicular cancer for the experimental group Exclusion Criteria: - Female for the experimental group - Second degree family members of Male testicular cancer patients - People with an age < 18 and > 90 - Diagnosis different from testicular cancer for the experimental group Incapacity to read and sign the informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members
The project aims to collect biological samples of saliva from testicular cancer patients and from their first-degree family members; demographic-clinical variables will be also collected in order to draft a comprehensive panel of genes and gene modifications related to the testicular cancer, combining this survey with a very detailed descprition of this cohort of patient in terms of clinical features and quality of life

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Outcome

Type Measure Description Time frame Safety issue
Primary Saliva biological sample Saliva biological samples will be collected from both patients with testicular cancer and their first-degree family members trough a buccal swab, that will be analysed with a whole exome sequencing (WES) in order to explore panel of genes Baseline
Secondary Demographic-clinical variables Demographic and clinical variables will be collected from the interview with the physician: 1)Age of the subject; 2. Age at diagnosis; 3. Ethnicity; 4.BMI; 5. Lifestyle (smoking, diet, alcohol, physical activity…); 6. Histotype of the neoplasm; 7; Nodule Size; Presence of embryonal carcinoma > 50%; 8. Percentage of necrosis present; 9. Basic pharmacological therapy; 10. Chemo/radiotherapy; Baseline
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