West-KOaSt: WEST-KOaST Study: WES Analysis of Testicular Cancer Patientsand Their First-degree Family Members

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06142500

Collaborator

(none)

4,500

Enrollment

Arms

33.7

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Testicular Cancer	Genetic: Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

WEST-KOaST Study: WES (Whole Exome Sequencing) Analysis of Testicular Cancer Patientsand Their First-degree Family Members

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Sep 21, 2025

Anticipated Study Completion Date :

Sep 21, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with testicular cancer Patient with testicular cancer	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
Active Comparator: First-degree family members of patients with testicular cancer First-degree family members of patients with testicular cancer	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

Arm

Intervention/Treatment

Experimental: Patients with testicular cancer

Patient with testicular cancer

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

Active Comparator: First-degree family members of patients with testicular cancer

First-degree family members of patients with testicular cancer

Genetic: Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members

Outcome Measures

Primary Outcome Measures

Saliva biological sample [Baseline]
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

Secondary Outcome Measures

Demographic-clinical variables [Baseline]
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;

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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