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Cancer Genetic Testing in Ethnic Populations

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Mayo Clinic

Status

Enrolling

Conditions

Central Nervous System Carcinoma
Malignant Female Reproductive System Neoplasm
Digestive System Carcinoma
Carcinoma of Unknown Primary
Malignant Brain Neoplasm
Head and Neck Carcinoma
Malignant Musculoskeletal Neoplasm
Skin Carcinoma
Malignant Solid Neoplasm
Genitourinary System Carcinoma
Breast Carcinoma

Treatments

Procedure: Biospecimen Collection
Other: Genetic Testing

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04475640
19-006717 (Other Identifier)
NCI-2020-04427 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,800 participants in 1 patient group

Screening (biospecimen collection)
Experimental group
Description:
Patients undergo collection of blood or saliva sample for genetic testing.
Treatment:
Other: Genetic Testing
Procedure: Biospecimen Collection

Trial contacts and locations

2

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Central trial contact

Clinical Trials Referral Office

Data sourced from clinicaltrials.gov

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