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Recruiting

NCT Number: NCT06008392

INTERogating Cancer for Etiology, Prevention and Therapy Navigation

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pan-genomic Testing

Genetic

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

Primary outcomes

  1. Genomic sequencing of tumor tissue and blood

    Time frame: Baseline; 50 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Katie M. Gano, M.S.

CONTACT

[email protected]

480-342-6082

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: INTERCEPTioN

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Aug 23, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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