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

NCT ID: NCT06142500

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-09-21

Brief Summary

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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

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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.

Conditions

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Testicular Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with testicular cancer

Patient with testicular cancer

Group Type EXPERIMENTAL

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

Intervention Type 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

First-degree family members of patients with testicular cancer

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Interventions

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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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Andrea Salonia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Salonia, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Central Contacts

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Andrea Salonia, MD

Role: CONTACT

+390226435661

Alessia d'Arma, MSc

Role: CONTACT

02 2643 5506

Other Identifiers

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West KOaSt

Identifier Type: -

Identifier Source: org_study_id