Cancer Genetic Testing in Ethnic Populations

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood sample

  • Genetic Testing

    Other intervention

    Undergo genetic testing

Treatment groups

1,800 Participants
are divided into 1 treatment group
Group A: Screening (biospecimen collection)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Study completion (2 years)
2

Prevalence of positive pathogenic germline mutations

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.

Time frame
Study completion (2 years)
3

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

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.

Time frame
Study completion (2 years)
4

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

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.

Time frame
Study completion (2 years)

Secondary outcomes

Other outcomes

Sponsors and contacts

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