INTERogating Cancer for Etiology, Prevention and Therapy Navigation

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer, Cancer Gene Mutation, PAN Gene Mutation

Intervention / Treatment
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* Genetic: Pan-genomic Testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with a confirmed cancer diagnosis<br>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<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whole Exome Sequencing (WES), Whole Genome Sequencing (WGS), Genetic Testing, Genetic Counseling, Genomics