Recruiting

Observational StudyINTERogating Cancer for Etiology, Prevention and Therapy Navigation

Sponsor:

Mayo Clinic

Code:

NCT06008392

Conditions

Cancer

Cancer Gene Mutation

PAN Gene Mutation

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pan-genomic Testing

Study Details

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.

Conditions

Cancer

Cancer Gene Mutation

PAN Gene Mutation

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06008392

Start date

Oct 12, 2023

Status verified date

Oct, 2026

Completion date

Sep, 2033

Anticipated

Primary completion date

Sep, 2033

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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).

Primary outcome measure

Genomic sequencing of tumor tissue and blood [ Time Frame: Baseline; 50 years ]

Central Contacts and Locations

Central contacts

Cancer Center CRC Team

507-266-7492 Interception@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Cancer Center CRC Team

507-266-7492 Interception@mayo.edu

Principal Investigator:

Jewel J. Samadder, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Cancer Center CRC Team

507-266-7492 Interception@mayo.edu

Principal Investigator:

Jeremy C. Jones, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Cancer Center CRC Team

507-266-7492 Interception@mayo.edu

Principal Investigator:

Mrinal S. Patnaik, MBBS

Mayo Clinic Health System-Eau Claire Clinic

Recruiting

Eau Claire, Wisconsin, United States, 54703

Contacts

Cancer Center CRC Team

507-266-7492 Interception@mayo.edu

Principal Investigator:

Samina Hirani, MBBS

Mayo Clinic Health System-Franciscan Healthcare

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Cancer Center CRC Team

507-266-7492 Interception@mayo.edu

Principal Investigator:

Tezo Karedan, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

Whole Exome Sequencing (WES)
Whole Genome Sequencing (WGS)
Genetic Testing
Genetic Counseling
Genomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.