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

Mayo Clinic

Status and phase

Completed

Phase 1

Conditions

Digestive System Neoplasm

Malignant Female Reproductive System Neoplasm

Malignant Head and Neck Neoplasm

Malignant Genitourinary System Neoplasm

Malignant Brain Neoplasm

Malignant Musculoskeletal Neoplasm

Skin Carcinoma

Malignant Solid Neoplasm

Breast Carcinoma

Metastatic Malignant Neoplasm of Unknown Primary

Malignant Central Nervous System Neoplasm

Treatments

Other: Genetic Testing

Procedure: Biospecimen Collection

Other: Genetic Counseling

Other: Survey Administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04456140

NCI-2020-04429 (Registry Identifier)

19-011472 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

230 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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