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

November 16, 2023 updated by: Andrea Salonia, IRCCS San Raffaele

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

4500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic-clinical variables
Time Frame: 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;
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Andrea Salonia, MD, IRCCS Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

September 21, 2025

Study Completion (Estimated)

September 21, 2026

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Estimated)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • West KOaSt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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