Recruiting

Genetic Testing

Sponsor:

Mayo Clinic

Code:

NCT04475640

Conditions

Breast Carcinoma

Carcinoma of Unknown Primary

Central Nervous System Carcinoma

Digestive System Carcinoma

Genitourinary System Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Genetic Testing

Study Details

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.

Conditions

Breast Carcinoma

Carcinoma of Unknown Primary

Central Nervous System Carcinoma

Digestive System Carcinoma

Genitourinary System Carcinoma

Study ID

NCT04475640

Start date

Jan 13, 2020

Status verified date

Apr, 2026

Completion date

Oct 15, 2028

Anticipated

Primary completion date

Oct 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1800 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Screening (biospecimen collection)

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

Interventions

Biospecimen Collection

Undergo collection of blood sample

Genetic Testing

Undergo genetic testing

Primary outcome measure

  • Prevalence of pathogenic germline mutations in enrolled patients within each cancer site [ Time Frame: Study completion (2 years) ]
  • Prevalence of positive pathogenic germline mutations [ Time Frame: Study completion (2 years) ]
  • Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria [ Time Frame: Study completion (2 years) ]
  • Impact of germline genetic testing on both therapeutic management and targeted cancer prevention [ Time Frame: Study completion (2 years) ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Jewel Samadder, M.D.

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Jeremy C. Jones, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 2, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-02.