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Pro-Active Genetic Testing in Patients with Solid Tumors, Inherit Study

Trial Status: Active

This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent’s Riverside. This may help doctors better understand and / or treat others who have genetic mutations.

Inclusion Criteria

  • Individuals diagnosed with any solid tumor cancer (stages 1-4) including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary
  • Blood collection is feasible (health, access and/or tolerability) for requested blood sample(s)
  • Individuals have agreed to participate and signed the study informed consent form

Exclusion Criteria

  • Individuals who do not meet study inclusion criteria
  • Individuals with an active hematologic malignancy
  • Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic or St Vincent’s Healthcare and available for review by the research coordinator at time of consent

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Niloy Jewel Samadder
Phone: 480-342-6263

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Contact: Jeremy Clifton Jones
Phone: 904-953-3309

PRIMARY OBJECTIVE:

I. To determine the prevalence of genetic mutations in cancer patients seeking care at the Mayo Clinic Cancer Center at St. Vincent’s Riverside in Jacksonville, Florida.

SECONDARY OBJECTIVES:

I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:

Ia. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network [NCCN]) based approach for genetic evaluation.

Ib. Determine the percentage of relatives of mutation positive probands undergoing family variant testing within a 3 month window of return of testing results.

Ic. Assess patient experience and barriers to care with a genetic service line via survey measures.

Id. Develop a biorepository of samples (blood) from cancer patients participating in this protocol.

OUTLINE:

Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.

Trial Phase Phase I

Trial Type Prevention

Lead Organization
Mayo Clinic in Arizona

Principal Investigator
Niloy Jewel Samadder

  • Primary ID 19-011472
  • Secondary IDs NCI-2020-04429
  • Clinicaltrials.gov ID NCT04456140