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

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

The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in "real world" practice conditions.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Cancer Gene Mutation; PAN Gene Mutation
• Intervention / Treatment: Genetic: Pan-genomic Testing

• Study Type: Observational
• Enrollment (Estimated): 1000

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
      • Not yet 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
      • Not yet 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

• Institutionalized (i.e. Federal Medical Prison),
• Prior germline genetic testing with a 40+ multi-gene panel within the last 1 year of enrollment, AND/OR
• Prior somatic (250+ gene) testing within the prior 3 months of enrollment

Note: Women who are pregnant or planning to become pregnant can take part in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants with a confirmed cancer diagnosis; Potential participants 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).

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): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Genomics; Genetic Testing; Genetic Counseling; Whole Genome Sequencing (WGS); Whole Exome Sequencing (WES)
• Other Study ID Numbers: 22-008878

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No