Genetic Testing in African Americans Towards Universal Paired Tumor/Germline Genetic Testing in Solid Tumor Patients With Specific Gynecological Malignancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Augusta University
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Consent rate for germline testing
Study Overview
Brief Summary
This is a pilot/feasibility study to conduct genetic testing using tumor/blood samples of African American and Caucasian patients with ovarian and endometrial cancer following surgery at AU Health Medical Center. The aim of the pilot/feasibility study is to sequence a panel of cancer genes on paired tumor/blood (germline) samples of patients with ovarian and endometrial tumors at a two-week time point following surgery at AU Medical Center. While paired testing of tumor and blood (germline) provides direct clinical value to patients, investigators propose to study whether investigators can define and overcome such minority barriers among the Georgia Cancer Center (GCC)/AU Health Medical Center (AUMC) patient population.
Detailed Description
The purpose of this study is to identify genetic mutations using a sequence a panel to detect cancer genes on paired tumor/blood (germline) samples particularly (AA) patients with ovarian, endometrial, fallopian or primary peritoneal carcinoma as AA individuals with cancer are less prone to accept a recommendation to undergo genetic testing. Approximately 30 subjects will participate in this study at Georgia Cancer Center/AU Health Medical Center.
Primary Objective:
To test the feasibility of this approach designed to provide a preliminary statistical analysis among the number of patients to overcome minority barriers among the GCC/AUMC patient population.
Secondary Objectives:
- Measure attitudes toward early testing.
- Compare rates of participation based on messaging of benefits between Caucasians and AA
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years of age.
- •New diagnosis of ovarian, endometrial, fallopian, or primary peritoneal carcinoma.
- •Diagnostic procedure performed at AU Health Medical Center.
- •Adequate tissue is available for the tumor testing component (e.g., cytology and FNA samples are typically not adequate, whereas core biopsies and open biopsies usually are adequate.
- •Consent at first post-biopsy outpatient clinic visit (typically about 2 weeks).
- •Ability to provide informed consent in English.
Exclusion Criteria
- •There are no exclusion criteria
Arms & Interventions
Study Time and Events Table
Study Procedures are as followed:
On Day 1 Surgery/biopsy will be performed to obtain ovarian and endometrial samples. Day 14 will include Informed consent, demographics collection and Blood samples will be obtained. Subjects will complete a survey about knowledge of, attitudes towards, and awareness of genetic testing use over 30 minutes on Day 14. Days 14-21 Tumor/blood DNA preparation. On Day 42 Genetic test results will be released and uploaded in the EMR. If the genetic testing is positive, genetic counseling will be scheduled.
Intervention: genetic testing (Other)
Study Time and Events Table
Study Procedures are as followed:
On Day 1 Surgery/biopsy will be performed to obtain ovarian and endometrial samples. Day 14 will include Informed consent, demographics collection and Blood samples will be obtained. Subjects will complete a survey about knowledge of, attitudes towards, and awareness of genetic testing use over 30 minutes on Day 14. Days 14-21 Tumor/blood DNA preparation. On Day 42 Genetic test results will be released and uploaded in the EMR. If the genetic testing is positive, genetic counseling will be scheduled.
Intervention: Survey Administration (Other)
Outcomes
Primary Outcomes
Consent rate for germline testing
Time Frame: 12 months
Percentage of all patients with ovarian and endometrial cancer who complete testing
Secondary Outcomes
- Comparison of rate of Participation(12 months)