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Trial Title:
Genetic Testing in African Americans
NCT ID:
NCT05591131
Condition:
Ovarian Cancer
Endometrial Cancer
Peritoneal Cancer
Conditions: Official terms:
Ovarian Neoplasms
Endometrial Neoplasms
Conditions: Keywords:
Black and African American Health
Genetic Testing
Ovarian Cancer
Endometrial Cancer
Peritoneal Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
genetic testing
Description:
Undergo genetic testing
Arm group label:
Study Time and Events Table
Other name:
genetic analysis
Other name:
Genetic Examination
Other name:
Genetic Test
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete survey
Arm group label:
Study Time and Events Table
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.
Criteria for 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
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Georgia Cancer Center at Augusta University
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashlyn Stevenson, RN
Phone:
706-721-0660
Email:
ASSTEVENSON@augusta.edu
Contact backup:
Last name:
GCC Clinical Trials Office
Phone:
7067212505
Email:
Cancer_Center_Trials@augusta.edu
Investigator:
Last name:
John W Henson, MD
Email:
Principal Investigator
Start date:
April 20, 2023
Completion date:
November 2027
Lead sponsor:
Agency:
Augusta University
Agency class:
Other
Source:
Augusta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05591131
