INTERCEPTioN: INTERogating Cancer for Etiology, Prevention and Therapy Navigation

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06008392

Collaborator

(none)

1,000

Enrollment

Locations

120

Anticipated Duration (Months)

333.3

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Cancer Gene Mutation PAN Gene Mutation	Genetic: Pan-genomic Testing

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2033

Anticipated Study Completion Date :

Sep 1, 2033

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

Genomic sequencing of tumor tissue and blood [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905