Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04475640

Cancer Genetic Testing in Ethnic Populations

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Carcinoma Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Carcinoma of Unknown Primary Central Nervous System Carcinoma Central Nervous System Diseases Central Nervous System Neoplasms Digestive System Carcinoma Genitourinary System Carcinoma Head and Neck Carcinoma Malignant Brain Neoplasm Malignant Female Reproductive System Neoplasm Malignant Musculoskeletal Neoplasm Malignant Solid Neoplasm Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplasms, Unknown Primary Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Carcinoma Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood sample

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Genetic Testing

Other

Undergo genetic testing

Other names: Genetic Analysis, Genetic Examination, Genetic Test

Primary outcomes

  1. Prevalence of pathogenic germline mutations in enrolled patients within each cancer site

    Time frame: Study completion (2 years)

    Will identify the prevalence of pathogenic germline mutations in enrolled patients within each cancer site, age (< 60 years old versus (vs.) >= 60 years old), and stage (early vs. advanced) via descriptive statistics.

  2. Prevalence of positive pathogenic germline mutations

    Time frame: Study completion (2 years)

    Will determine whether the prevalence of positive pathogenic germline mutations differs between cancer sites, age of diagnosis, and stage of diagnosis using logistic regression analysis across all cancer site groups and pairwise post-hoc analyses using Tukey's correction for multiple comparisons across pairs of cancer sites and chi-square tests of differences between age and stage groups.

  3. Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria

    Time frame: Study completion (2 years)

    Will compare the rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria within cancer site, age, and stage using logistic regression and pairwise post-hoc analyses as needed.

  4. Impact of germline genetic testing on both therapeutic management and targeted cancer prevention

    Time frame: Study completion (2 years)

    Will assess the impact of germline genetic testing on both therapeutic management and targeted cancer prevention in family members using logistic regression and pairwise post-hoc analyses as needed.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

GEMINI - Cancer Genetic Testing in Ethnic Populations

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2020
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.