Genetic Testing in African Americans

Ovarian Cancer Clinical Trial

— GTM-I  

Official title:

Genetic Testing in African Americans Towards Universal Paired Tumor/Germline Genetic Testing in Solid Tumor Patients With Specific Gynecological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591131
• Other study ID #: GTM-I
• Secondary ID: Paceline
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: November 2027

Study information

• Verified date: July 2023
• Source: Augusta University
• Contact: Ashlyn Stevenson
• Phone: 706-721-0660
• Email: ASSTEVENSON[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

Other:
• genetic testing
Undergo genetic testing
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	Georgia Cancer Center at Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consent rate for germline testing	Percentage of all patients with ovarian and endometrial cancer who complete testing	12 months
Secondary	Comparison of rate of Participation	Compare rates of participation based upon the patient's understanding the message regarding benefit and based upon her race.	12 months