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Clinical Trials/NCT06142500
NCT06142500
Not yet recruiting
Not Applicable

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

IRCCS San Raffaele0 sites4,500 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Testicular Cancer
Sponsor
IRCCS San Raffaele
Enrollment
4500
Primary Endpoint
Saliva biological sample
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
September 21, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Salonia

Professor

IRCCS San Raffaele

Eligibility Criteria

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

Outcomes

Primary Outcomes

Saliva biological sample

Time Frame: 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 Outcomes

  • Demographic-clinical variables(Baseline)

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