Analyzing cancer genetics for better prevention and treatment
INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)
This study is trying to find genetic clues in cancer patients' samples to improve prevention and treatment options for cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT06008392 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify genetic markers and causes of cancer by analyzing patients' DNA, RNA, plasma, tissues, and other samples. It focuses on cancer genetic testing to find specific changes in cancer and normal cells, which may lead to improved prevention, screening, and treatment strategies. Additionally, the study will create a biobank of samples and information to further research in cancer treatment. Participants will undergo pan-genomic testing to discover genetic variants that could enhance cancer management.
Who should consider this trial
Good fit: Ideal candidates include individuals with a confirmed cancer diagnosis who can provide genetic samples and are aware of their condition.
Not a fit: Patients who are not diagnosed with cancer or unable to provide the necessary samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and more effective therapies for cancer patients.
How similar studies have performed: Other studies utilizing genetic testing for cancer have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: GROUP A: Germline and Somatic Testing * Has Mayo Clinic medical record number * Confirmed cancer diagnosis * Germline and/or somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate) * Participant aware of cancer diagnosis * Able to provide informed consent * ≥ 18 years old * Ability to provide blood, saliva, bone marrow aspirate or hair follicle sample * Ability to provide archived tissue, if somatic testing has not already been completed * Note: if tissue unavailable participant may still enroll onto the study for the germline collection, or vice versa, if germline has already been completed may still enroll for somatic tissue/blood testing. GROUP B: Germline testing only: * Has Mayo Clinic medical record number * Confirmed cancer diagnosis * Germline testing has been ordered by the clinical provider (or clinical delegate) * Participant aware of cancer diagnosis * Able to provide informed consent * ≥ 18 years old * Ability to provide blood, saliva, or hair follicle sample GROUP C: Somatic tumor testing only: * Has Mayo Clinic medical record number, * Confirmed cancer diagnosis, * Somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate) * Participant aware of cancer diagnosis, * Able to provide informed consent, * ≥ 18 years old * Ability to provide archived tissue or blood for somatic tumor genomic profiling, if not already completed. Group D: Clinical standard of care germline testing via genetic counselor: * Has Mayo Clinic medical record number, * Standard of care clinical visit with genetic counselor * Confirmed cancer diagnosis, * Germline testing has been ordered by the clinical provider (or clinical delegate) * Participant aware of cancer diagnosis, * Able to provide informed consent, * ≥ 18 years old * Ability to provide blood, saliva, or hair follicle sample Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810: * Enrolled in any of the following studies: IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810 * Completed Riskguard, OncoExtra, Caris Assure, or Caris MI Profile or any combination of these tests. * Has Mayo Clinic medical record number, * Confirmed cancer diagnosis, * Participant aware of cancer diagnosis * Able to provide informed consent, * ≥ 18 years old Exclusion Criteria: Note: Women who are pregnant or planning to become pregnant can take part in this study. GROUP A: Germline and Somatic testing * Individuals who have situations that would limit compliance with the study requirements * Institutionalized (i.e. Federal Medical Prison) GROUP B: Germline testing only * Individuals who have situations that would limit compliance with the study requirements * Institutionalized (i.e. Federal Medical Prison) * Prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment Group C: Somatic tumor testing only: * Individuals who have situations that would limit compliance with the study requirements, * Institutionalized (i.e. Federal Medical Prison), Group D: Clinical standard of care germline testing via genetic counselor: * Individuals who have situations that would limit compliance with the study requirements, * Institutionalized (i.e. Federal Medical Prison) Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810: * Individuals who have situations that would limit compliance with the study requirements, * Institutionalized (i.e. Federal Medical Prison)
Where this trial is running
Scottsdale, Arizona and 2 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jewel J. Samadder, M.D. — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.