Breast Carcinoma, Digestive System Neoplasm, Malignant Brain Neoplasm, Malignant Central Nervous System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Genitourinary System Neoplasm, Malignant Head and Neck Neoplasm, Malignant Musculoskeletal Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm of Unknown Primary, Skin Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood samples
OTHERGenetic Counseling
Watch pre-test genetic counseling video
OTHERGenetic Testing
Undergo genetic testing
OTHERSurvey Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals diagnosed with any solid tumor cancer (stages 1-4) including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary * 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
* Individuals who do not meet study inclusion criteria * Individuals with an active hematologic malignancy * Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic or St Vincent's Healthcare and available for review by the research coordinator at time of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of mutation detection | Up to 3 months | 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. |
| Prevalence of pathogenic germline mutations | Up to 3 months | Will be assessed by each cancer site, age (\< 60 years old versus \[vs.\] \>= 60 years old), and stage (early vs. advanced) via descriptive statistics. |
| Difference between prevalence of positive pathogenic germline mutations | Up to 3 months | 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. |
| Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families | Up to 3 months | Assessed using logistic regression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in survey responses between patient groups | Up to 3 months | 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). |
Countries
United States
Outcome results
None listed