Genetic Testing in African Americans

NCT ID: NCT05591131

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2027-11-30

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.

Conditions

Ovarian Cancer; Endometrial Cancer; Peritoneal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

genetic testing

Intervention Type: OTHER

Undergo genetic testing

Survey Administration

Intervention Type: OTHER

Complete survey

Interventions

genetic testing

Undergo genetic testing

Intervention Type: OTHER

Survey Administration

Complete survey

Intervention Type: OTHER

Other Intervention Names

genetic analysis; Genetic Examination; Genetic Test

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Countries

United States

Other Identifiers

Paceline

Identifier Type: OTHER

Identifier Source: secondary_id

GTM-I

Identifier Type: -

Identifier Source: org_study_id