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RECRUITING

NCT06008392

INTERogating Cancer for Etiology, Prevention and Therapy Navigation

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2023-10-12

Completion Date

2033-09

Last Updated

2026-04-07

Healthy Volunteers

Conditions

Cancer Cancer Gene Mutation PAN Gene Mutation Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Interventions

GENETIC

Pan-genomic Testing

Participants will be scheduled to review the study specifics, review consent and gather medical information. Once consented, samples will be collected. When the samples are received by Exact Sciences, DNA and RNA will be extracted, and sequencing will be performed. Following pan-genomic testing, participants will receive the full report with results from their care team and results will also be added to the patient's portal. If a germline finding is identified (positive pathogenic variant) the participant will also be referred for a genetic counselor visit. All results from the germline hereditary test will be reviewed by a certified genetic counselor in addition to a review of their pedigree. To help with review of any genetic research findings, the study team may request to obtain genomic data from previous genetic testing (clinical or research based).

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)

Locations (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States