Cancer Clinical Trial
— INTERCEPTioNOfficial title:
INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)
NCT number | NCT06008392 |
Other study ID # | 22-008878 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 12, 2023 |
Est. completion date | September 2033 |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
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 |
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