Clinical trial NCT04475640: Cancer Genetic Testing in Ethnic Populations
Official title: GEMINI - Cancer Genetic Testing in Ethnic Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Carcinoma of Unknown Primary
Central Nervous System Carcinoma
Digestive System Carcinoma
Genitourinary System Carcinoma
Head and Neck Carcinoma
Malignant Brain Neoplasm
Malignant Female Reproductive System Neoplasm
Malignant Musculoskeletal Neoplasm
Malignant Solid Neoplasm
Skin Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic Arizona and Mayo Clinic Florida cancer clinics.

SECONDARY OBJECTIVES:

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

Ia. Determine prevalence of pathogenic germline mutation detected by multi-gene panel testing.

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

OUTLINE:

Patients undergo collection of blood or saliva sample for genetic testing.

Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age
* Individuals diagnosed with any solid tumor cancer including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary; and presenting to Mayo Clinic (MC Arizona or MC Florida) for clinical management/treatment; and patients receive genetic testing as described above
* Self-identified as being from various ethnic populations including Hispanic/Latino, Native American/Alaskan, African American (including of African descent), Asian and other European populations
* 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:

* Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic and available for review by the research coordinator at time of consent
* Past or current history of hematological cancer (including leukemias, multiple myeloma)
* All bone marrow transplants

Primary outcomes:
measure: Prevalence of pathogenic germline mutations in enrolled patients within each cancer site
timeFrame: Study completion (2 years)
measure: Prevalence of positive pathogenic germline mutations
timeFrame: Study completion (2 years)
measure: Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria
timeFrame: Study completion (2 years)
measure: Impact of germline genetic testing on both therapeutic management and targeted cancer prevention
timeFrame: Study completion (2 years)
Secondary outcomes:
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: Jewel Samadder, M.D.
role: PRINCIPAL_INVESTIGATOR
References: