INTERogating Cancer for Etiology, Prevention and Therapy Navigation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Individuals who have situations that would limit compliance with the study requirements

Institutionalized (i.e. Federal Medical Prison)

Individuals who have situations that would limit compliance with the study requirements

Institutionalized (i.e. Federal Medical Prison)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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).

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Group A: Germline and Somatic Testing1 intervention
Group B: Group B: Germline Testing Only1 intervention

Trial outcomes

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.

Time frame
Baseline; 50 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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