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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Cancer; Hematopoietic and Lymphoid System Neoplasm; Cancer Gene Mutation; PAN Gene Mutation
• Intervention / Treatment: Genetic: Pan-genomic Testing

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Katie M. Gano, M.S.; Phone Number: 480-342-6082; Email: Gano.Katherine@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Jewel J. Samadder, M.D.
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Principal Investigator: Jeremy C. Jones, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Mrinal S. Patnaik, M.B.B.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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).; Other Names: Genetic testing
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.	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).; Other Names: Genetic testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jewel J. Samadder, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2033

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Genomics; Genetic Testing; Genetic Counseling; Whole Genome Sequencing (WGS); Whole Exome Sequencing (WES)
• Additional Relevant MeSH Terms: Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Genetic Techniques; Genetic Services; Diagnostic Services; Genetic Testing
• Other Study ID Numbers: 22-008878; NCI-2024-03113 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No