NCT06008392 INTERogating Cancer for Etiology, Prevention and Therapy Navigation
| NCT ID | NCT06008392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-10-12 |
| Primary Completion | 2033-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-10-12 with a primary completion date of 2033-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being done to identify markers and causes of cancer by analyzing patient's DNA (i.e., genetic material), RNA, plasma, tissues, or other samples that could be informative for patients with cancer. Cancer genetic testing is a series of tests that finds specific changes in cancer cells and normal cells in the body. Researchers may request to access these data as they explore how to better prevent, screen, or treat cancer. This study is also being done to create a biobank (library) of samples and information to learn more about treating cancer. Discovery of genetic variants in patients with cancer could result in opportunities for cancer prevention, earlier diagnosis or better therapy for cancer.
Eligibility 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)
Contact & Investigator
Jewel J. Samadder, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06008392 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06008392 currently recruiting?
Yes, NCT06008392 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06008392 trial being conducted?
This trial is being conducted at Scottsdale, United States, Jacksonville, United States, Rochester, United States.
Who is sponsoring the NCT06008392 clinical trial?
NCT06008392 is sponsored by Mayo Clinic. The principal investigator is Jewel J. Samadder, M.D. at Mayo Clinic. The trial plans to enroll 500 participants.
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