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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04429 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-011472 | Other Identifier | Mayo Clinic in Arizona |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (pre-genetic test counseling, genetic testing) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of pathogenic germline mutations | Will be assessed by each cancer site, age (< 60 years old versus [vs.] >= 60 years old), and stage (early vs. advanced) via descriptive statistics. | Up to 3 months |
| Difference between prevalence of positive pathogenic germline mutations | 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. | Up to 3 months |
| Rate of mutation detection | 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. | Up to 3 months |
| Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families | Assessed using logistic regression | Up to 3 months |
| Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families | Assessed using pairwise post-hoc analyses | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in survey responses between patient groups | 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). | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niloy J Samadder | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
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| Genetic Counseling | Other | Watch pre-test genetic counseling video |
|
| Genetic Testing | Other | Undergo genetic testing |
|
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| Survey Administration | Other | Ancillary studies |
|
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004067 | Digestive System Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D014565 | Urogenital Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009382 | Neoplasms, Unknown Primary |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004066 | Digestive System Diseases |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005817 | Genetic Counseling |
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
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