Ovarian CancerGTM-INCT05591131
Genetic Testing in African Americans
A study testing genetic testing and Survey Administration in people with Ovarian Cancer and Endometrial Cancer, run by Augusta University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Peritoneal Cancer
- What is being tested?
- genetic testing and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
About this study
Official title: Genetic Testing in African Americans Towards Universal Paired Tumor/Germline Genetic Testing in Solid Tumor Patients With Specific Gynecological Malignancies
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.
Read the 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
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
- Being tested
- genetic testing, Survey Administration
- Keywords
- Black and African American Health, Genetic Testing, Ovarian Cancer, Endometrial Cancer, Peritoneal Cancer
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic testingOther
Also called genetic analysis, Genetic Examination, Genetic Test
Undergo genetic testing
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Study Time and Events Table | Experimental | 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. Receives: Other: genetic testing; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate for germline testing
Percentage of all patients with ovarian and endometrial cancer who complete testing
Measured: 12 months
Secondary outcomes (1)
Comparison of rate of Participation
Compare rates of participation based upon the patient's understanding the message regarding benefit and based upon her race.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start20 Apr 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591131
- Sponsor's protocol ID
- GTM-I
- Other IDs
- Paceline
- Acronym
- GTM-I
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2022
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Testing in African Americans Towards Universal Paired Tumor/Germline Genetic Testing in Solid Tumor Patients With Specific Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT05591131
- Acronym / sponsor ID
- GTM-I / GTM-I
- Conditions
- Ovarian Cancer, Endometrial Cancer, Peritoneal Cancer
- Keywords
- Black and African American Health, Genetic Testing, Ovarian Cancer, Endometrial Cancer, Peritoneal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Time and Events Table | Experimental | Other: genetic testing, Other: Survey AdministrationStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- There are no exclusion criteria
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic testingAlso: genetic analysis, Genetic Examination, Genetic TestUndergo genetic testing | Other | Study Time and Events Table |
| Survey AdministrationComplete survey | Other | Study Time and Events Table |
Primary outcome
Consent rate for germline testing
Time frame: 12 months
Percentage of all patients with ovarian and endometrial cancer who complete testing
1 secondary outcome
Comparison of rate of Participation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genetic testing and Survey Administration in people with Ovarian Cancer and Endometrial Cancer, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate for germline testing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.