Cancer Genetic Testing in Ethnic Populations

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04475640
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Niloy J. Samadder, M.D.
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Screening (biospecimen collection)

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

Interventions

Procedure: - Biospecimen Collection

Undergo collection of blood sample

Other: - Genetic Testing

Undergo genetic testing

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Arizona, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

Mayo Clinic in Florida, Jacksonville, Florida