West-KOaSt: WEST-KOaST Study: WES Analysis of Testicular Cancer Patientsand Their First-degree Family Members
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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 Design
Arms and Interventions
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 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
|
Outcome Measures
Primary Outcome Measures
- Saliva biological sample [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 Outcome Measures
- Demographic-clinical variables [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;
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male testicular cancer patients with an age > 18 and < 90
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First degree family members of Male testicular cancer patients with an age > 18 and < 90
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Ability to read and sign the informed consent
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Diagnosis of testicular cancer for the experimental group
Exclusion Criteria:
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Female for the experimental group
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Second degree family members of Male testicular cancer patients
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People with an age < 18 and > 90
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Diagnosis different from testicular cancer for the experimental group Incapacity to read and sign the informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- IRCCS San Raffaele
Investigators
- Principal Investigator: Andrea Salonia, MD, IRCCS Ospedale San Raffaele
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- West KOaSt