INTERogating Cancer for Etiology, Prevention and Therapy Navigation
INTERCEPTioN
2 other identifiers
observational
350
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedStudy Start
First participant enrolled
October 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2033
October 10, 2025
October 1, 2025
9.9 years
August 8, 2023
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Genomic sequencing of tumor tissue and blood
Genomic sequencing of tumor tissue and blood will be performed to determine genomic alterations in germline and somatic cancer-related genes (SNVs, indels, CNVs from DNA and fusions from RNA) to allow the ordering hematologist/oncologist/provider to determine optimal therapy and clinical trial prospective. Researchers across the field of genomic sequencing report findings about new variations in scientific publications and collect it in databases every day. Consequently, any patient's variant of uncertain significance (VUS) result could be reclassified by emerging findings, turning previously unresolved tests into diagnostic answers. Our Translational Omics Program has a system to re-analyze a patient's exome/genome data against these new genetic findings-reviewing data and comparing it with emerging clinical genetic data to facilitate diagnoses.
Baseline; 50 years
Study Arms (2)
Group A: Germline and Somatic Testing
Potential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made.
Group B: Germline Testing Only
Potential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made.
Interventions
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).
Eligibility Criteria
Participants identified internally to Mayo Clinic will be enrolled. The Mayo Clinic study team and/or subspecialty teams will identify participants that fulfill enrollment criteria. Only individuals with a confirmed cancer diagnosis who know they have cancer will be asked to participate. Group B will enroll patients who do not meet NCCN and CMS guidelines for somatic tissue testing and/or whom have had somatic tissue testing, but not germline testing previously.
You may qualify if:
- GROUP A: Germline and Somatic Testing
- Has Mayo Clinic medical record number
- Confirmed cancer diagnosis which is either recurrent, relapsed, refractory, metastatic, or advanced
- Participant aware of cancer diagnosis
- Able to provide informed consent
- Ability to provide blood, saliva, bone marrow aspirate or hair follicle sample
- Ability to provide archived tissue, 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 testing.
- GROUP B: Germline testing only:
- Has Mayo Clinic medical record number
- Confirmed cancer diagnosis
- Participant aware of cancer diagnosis
- Able to provide informed consent
- Ability to provide blood, saliva, or hair follicle sample
You may not qualify if:
- 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)
- Prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment, AND/OR
- Prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Biospecimen
Each participant will have residual/archived tissue and a new blood (or saliva, hair follicle) sample for pan-genomic testing as per standard of care testing. Additional samples (including but not limited to tissue, bone marrow, blood, urine, stool, hair follicles, etc) may be requested/collected to be used for additional genomic and other omics studies.
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jewel J. Samadder, M.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 50 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2023
First Posted
August 23, 2023
Study Start
October 12, 2023
Primary Completion (Estimated)
September 1, 2033
Study Completion (Estimated)
September 1, 2033
Last Updated
October 10, 2025
Record last verified: 2025-10