RecruitingNCT06008392

INTERogating Cancer for Etiology, Prevention and Therapy Navigation

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

Sponsor

Mayo Clinic

Enrollment

500 participants

Start Date

Oct 12, 2023

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 18 Years

Inclusion Criteria43

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 Criteria17

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)

Interested in this trial?

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Interventions

GENETICPan-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).