Clinical trial NCT04456140: Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study
Official title: Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent's Mayo Clinic Embedded Cancer Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Carcinoma
Digestive System Neoplasm
Malignant Brain Neoplasm
Malignant Central Nervous System Neoplasm
Malignant Female Reproductive System Neoplasm
Malignant Genitourinary System Neoplasm
Malignant Head and Neck Neoplasm
Malignant Musculoskeletal Neoplasm
Malignant Solid Neoplasm
Metastatic Malignant Neoplasm of Unknown Primary
Skin Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of pathogenic germline mutations
timeFrame: Up to 3 months
measure: Difference between prevalence of positive pathogenic germline mutations
timeFrame: Up to 3 months
measure: Rate of mutation detection
timeFrame: Up to 3 months
measure: Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families
timeFrame: Up to 3 months
measure: Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families
timeFrame: Up to 3 months
Secondary outcomes:
measure: Differences in survey responses between patient groups
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Niloy J Samadder
role: PRINCIPAL_INVESTIGATOR
References: