INTERogating Cancer for Etiology, Prevention and Therapy Navigation

Cancer Clinical Trial

— INTERCEPTioN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008392
• Other study ID #: 22-008878
• Status: Recruiting
• Start date: October 12, 2023
• Est. completion date: September 2033

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2033
• Est. primary completion date: September 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cancer Gene Mutation

Intervention

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).

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials