Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Breast Neoplasms

Brain Neoplasms

Genital Neoplasms, Female

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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

Biospecimen Collection

Genetic Testing

Clinical Trials Referral Office

Niloy J. Samadder, M.D.

Jeremy C. Jones, M.D.

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.

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.

Cancer Genetic Testing in Ethnic Populations

GEMINI - Cancer Genetic Testing in Ethnic Populations

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.

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.

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.

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.

Mayo Clinic

Digestive System Diseases

Symptoms and General Pathology

Head and Neck Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms, Unknown Primary

Gastrointestinal Diseases

Neoplasm Metastasis

Neoplastic Processes

Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.

Genetic Counseling

Survey Administration

Niloy J Samadder

This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent's Riverside. This may help doctors better understand and/or treat others who have genetic mutations.

PRIMARY OBJECTIVE:

I. To determine the prevalence of genetic mutations in cancer patients seeking care at the Mayo Clinic Cancer Center at St. Vincent's Riverside in Jacksonville, Florida.

SECONDARY OBJECTIVES:

I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:

Ia. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network \[NCCN\]) based approach for genetic evaluation.

Ib. Determine the percentage of relatives of mutation positive probands undergoing family variant testing within a 3 month window of return of testing results.

Ic. Assess patient experience and barriers to care with a genetic service line via survey measures.

Id. Develop a biorepository of samples (blood) from cancer patients participating in this protocol.

OUTLINE:

Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.

Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study

Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent's Mayo Clinic Embedded Cancer Center

Will be assessed by each cancer site, age (\< 60 years old versus \[vs.\] \>= 60 years old), and stage (early vs. advanced) via descriptive statistics.

Will be assessed by 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.

Will be compared 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.

Assessed using pairwise post-hoc analyses

Patients will be grouped by genetic test result (positive vs. negative), age (\< 60 years old vs. \>= 60 years old), stage (early vs. advanced), and over time (enrollment vs. after test results are received).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Genetic Testing in Ethnic Populations	NCT04475640	Breast Carcinom... Carcinoma of Un... Central Nervous... Digestive Syste... Genitourinary S... Head and Neck C... Malignant Brain... Malignant Femal... Malignant Muscu... Malignant Solid... Skin Carcinoma	Biospecimen Col... Genetic Testing	18 Years -	Mayo Clinic
Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study	NCT04456140	Breast Carcinom... Digestive Syste... Malignant Brain... Malignant Centr... Malignant Femal... Malignant Genit... Malignant Head ... Malignant Muscu... Malignant Solid... Metastatic Mali... Skin Carcinoma	Biospecimen Col... Genetic Counsel... Genetic Testing Survey Administ...	18 Years -	Mayo Clinic
Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study	NCT04456140	Breast Carcinom... Digestive Syste... Malignant Brain... Malignant Centr... Malignant Femal... Malignant Genit... Malignant Head ... Malignant Muscu... Malignant Solid... Metastatic Mali... Skin Carcinoma	Biospecimen Col... Genetic Counsel... Genetic Testing Survey Administ...	18 Years -	Mayo Clinic
Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study	NCT04456140	Breast Carcinom... Digestive Syste... Malignant Brain... Malignant Centr... Malignant Femal... Malignant Genit... Malignant Head ... Malignant Muscu... Malignant Solid... Metastatic Mali... Skin Carcinoma	Biospecimen Col... Genetic Counsel... Genetic Testing Survey Administ...	18 Years -	Mayo Clinic
Cancer Genetic Testing in Ethnic Populations	NCT04475640	Breast Carcinom... Carcinoma of Un... Central Nervous... Digestive Syste... Genitourinary S... Head and Neck C... Malignant Brain... Malignant Femal... Malignant Muscu... Malignant Solid... Skin Carcinoma	Biospecimen Col... Genetic Testing	18 Years -	Mayo Clinic
Cancer Genetic Testing in Ethnic Populations	NCT04475640	Breast Carcinom... Carcinoma of Un... Central Nervous... Digestive Syste... Genitourinary S... Head and Neck C... Malignant Brain... Malignant Femal... Malignant Muscu... Malignant Solid... Skin Carcinoma	Biospecimen Col... Genetic Testing	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for malignant musculoskeletal neoplasm