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

Testicular Cancer Clinical Trial

— West-KOaSt  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06142500
• Other study ID #: West KOaSt
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

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