INTERogating Cancer for Etiology, Prevention and Therapy Navigation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pan-genomic Testing.
- Who it may be relevant to
- Registry conditions: Cancer, Cancer Gene Mutation, PAN Gene Mutation, Hematopoietic and Lymphoid System Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)
Overview
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.
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 p
Primary outcome measures
- Genomic sequencing of tumor tissue and blood [Time frame: Baseline; 50 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Mayo Clinic in Arizona — Scottsdale
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06008392 · 22-008878 · NCI-2024-03113