Clinical trial NCT05591131: Genetic Testing in African Americans
Official title: Genetic Testing in African Americans Towards Universal Paired Tumor/Germline Genetic Testing in Solid Tumor Patients With Specific Gynecological Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Endometrial Cancer
Peritoneal Cancer
Keywords: Black and African American Health
Genetic Testing
Ovarian Cancer
Endometrial Cancer
Peritoneal Cancer
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. Measure attitudes toward early testing.
2. Compare rates of participation based on messaging of benefits between Caucasians and AA

Subjects must meet all inclusion criteria of the study. There are no exclusion criteria.

Patients will be identified by an AU Health gynecologic oncologist (SG, BR, RH). A research coordinator will be deployed to the clinic at the 2-week post-biopsy visit.

All subjects who consent to participate a clinical research coordinator will ask for their permission to provide a matched tumor and blood sample for genetic testing. If consented the subjects will be given a questionnaire regarding their knowledge of genetic testing for germline mutations. Tumor and blood samples will be collected for testing and sent to the Georgia Esoteric and Molecular Laboratory. It is estimated that it will take approximately one year to fully accrue and complete assessments on all participants entered on this study.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years of age.
2. New diagnosis of ovarian, endometrial, fallopian, or primary peritoneal carcinoma.
3. Diagnostic procedure performed at AU Health Medical Center.
4. 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.
5. Consent at first post-biopsy outpatient clinic visit (typically about 2 weeks).
6. Ability to provide informed consent in English.

Exclusion Criteria:

There are no exclusion criteria

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Primary outcomes:
measure: Consent rate for germline testing
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of rate of Participation
timeFrame: 12 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
Study officials:
References: