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Cancer Genetic Testing in Ethnic Populations

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ClinicalTrials.gov Identifier: NCT04475640
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : July 18, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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Brief Summary:
This study 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.

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

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arms and Interventions
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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:
  • genetic analysis
  • Genetic Examination
  • Genetic Test


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Niloy J Samadder Mayo Clinic
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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