Cancer Genetic Testing in Ethnic Populations
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04475640 |
Recruitment Status :
Recruiting
First Posted : July 17, 2020
Last Update Posted : July 18, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Procedure: Biospecimen Collection Other: Genetic Testing | Not Applicable |
PRIMARY OBJECTIVE:
I. To determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic Arizona 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Gemini - Cancer Genetic Testing in Ethnic Populations |
Actual Study Start Date : | November 21, 2019 |
Estimated Primary Completion Date : | October 15, 2022 |
Estimated Study Completion Date : | October 15, 2023 |

Arm | Intervention/treatment |
---|---|
Ancillary-correlative (biospecimen collection)
Patients undergo collection of blood or saliva sample for genetic testing.
|
Procedure: Biospecimen Collection
Undergo collection of blood sample Other: Genetic Testing Undergo genetic testing
Other Names:
|
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475640
United States, Arizona | |
Mayo Clinic in Arizona | Recruiting |
Scottsdale, Arizona, United States, 85259 | |
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
Principal Investigator: Niloy J. Samadder, M.D. | |
United States, Florida | |
Mayo Clinic in Florida | Recruiting |
Jacksonville, Florida, United States, 32224-9980 | |
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
Principal Investigator: Jeremy C. Jones, M.D. |
Principal Investigator: | Niloy J Samadder | Mayo Clinic |
Responsible Party: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT04475640 |
Other Study ID Numbers: |
19-006717 NCI-2020-04427 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 19-006717 ( Other Identifier: Mayo Clinic in Arizona ) P30CA015083 ( U.S. NIH Grant/Contract ) |
First Posted: | July 17, 2020 Key Record Dates |
Last Update Posted: | July 18, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Neoplasms Breast Neoplasms Brain Neoplasms Genital Neoplasms, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms by Site |
Breast Diseases Skin Diseases Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Urogenital Neoplasms |