Testicular CancerWest-KOaStNCT06142500
WEST-KOaST Study: WES Analysis of Testicular Cancer Patientsand Their First-degree Family Members
A study testing Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members in people with Testicular Cancer, run by IRCCS San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 21 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Testicular Cancer
- Being tested
- Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members
- Keywords
- testicular cancer, cancer, familiarity, genetic, male infertility
- Medical subject headings
- Testicular Neoplasms, Neoplasms, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family membersGenetic
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with testicular cancer | Experimental | Patient with testicular cancer Receives: Genetic: Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members |
| First-degree family members of patients with testicular cancer | Active comparator | First-degree family members of patients with testicular cancer Receives: Genetic: Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva biological sample
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
Measured: Baseline
Secondary outcomes (1)
Demographic-clinical variables
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;
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion21 Sep 2025 (estimated)
- Study completion21 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
- Investigators
- Andrea Salonia, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142500
- Sponsor's protocol ID
- West KOaSt
- Acronym
- West-KOaSt
- Status last verified
- Nov 2023
- First submitted
- 9 Oct 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEST-KOaST Study: WES (Whole Exome Sequencing) Analysis of Testicular Cancer Patientsand Their First-degree Family Members
- ClinicalTrials.gov ID
- NCT06142500
- Acronym / sponsor ID
- West-KOaSt / West KOaSt
- Conditions
- Testicular Cancer
- Keywords
- testicular cancer, cancer, familiarity, genetic, male infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 21 Sep 2025 (estimated)
- Study completion
- 21 Sep 2026 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with testicular cancer | Experimental | Genetic: Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family membersPatient with testicular cancer |
| First-degree family members of patients with testicular cancer | Active comparator | Genetic: Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family membersFirst-degree family members of patients with testicular cancer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family membersThe 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 | Genetic | First-degree family members of patients with testicular cancer, Patients with testicular cancer |
Primary outcome
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
1 secondary outcome
Demographic-clinical variables
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Salonia, MD principal investigator
IRCCS Ospedale San Raffaele
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of biological samples of saliva from testicular cancer patients and from their first-degree family members in people with Testicular Cancer, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Salonia, MD (+390226435661, salonia.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva biological sample (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.