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

NCT06142500 | Not Yet Recruiting DMC

• 1 other identifier: West KOaSt
• Study Type: interventional
• Target: 4,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Testicular Cancer

Keywords

testicular cancer; cancer; familiarity; genetic; male infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Demographic-clinical variables

  Baseline

Study Arms (2)

Patients with testicular cancer

EXPERIMENTAL

Patient with testicular cancer

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

First-degree family members of patients with testicular cancer

ACTIVE COMPARATOR

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

Interventions

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

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

First-degree family members of patients with testicular cancer; Patients with testicular cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Testicular Neoplasms; Neoplasms; Infertility, Male

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Infertility

Study Officials

• Andrea Salonia, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Salonia, MD

CONTACT

+390226435661; salonia.andrea@hsr.it

Alessia d'Arma, MSc

CONTACT

02 2643 5506; darma.alessia@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 21, 2023
• Study Start: December 1, 2023
• Primary Completion: September 21, 2025
• Study Completion (Estimated): September 21, 2026
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share