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NCT Number: NCT06142500

WEST-KOaST Study: WES 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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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;

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia d'Arma, MSc

CONTACT

[email protected]

02 2643 5506

Andrea Salonia, MD

CONTACT

[email protected]

+390226435661

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: West-KOaSt

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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