Genetic Testing for Ovarian and Endometrial Cancer
(GTM-I Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What safety data exists for genetic testing in ovarian and endometrial cancer?
The safety data for genetic testing in ovarian and endometrial cancer primarily focuses on the acceptance and outcomes of genetic counseling and testing. Studies show that genetic counseling and testing are generally well-accepted by patients, with a significant number undergoing testing to assess cancer risk for themselves and their relatives. The detection of BRCA1/2 mutations and recommendations for surveillance highlight the importance of genetic testing in cancer prevention. Challenges include underreporting of family history and the need for systematic follow-up to ensure patients attend genetic assessments. Next-generation sequencing is being incorporated into clinical practice, though it presents challenges such as interpreting uncertain findings and ensuring informed consent.12345
Is genetic testing for ovarian and endometrial cancer safe for humans?
Genetic testing, including for ovarian and endometrial cancer, is generally considered safe for humans. It involves analyzing DNA to identify mutations that may increase cancer risk, and while it can provide important information, it does not involve any physical intervention that would pose a direct risk to health.12345
Is genetic testing a promising treatment for ovarian and endometrial cancer?
Yes, genetic testing is promising for ovarian and endometrial cancer because it helps in early detection, risk assessment, and prevention. It allows doctors to identify genetic mutations that increase cancer risk, leading to better prevention strategies for patients and their families. It also supports personalized medicine, which means treatments can be tailored to individual needs.12678
How is genetic testing different from other treatments for ovarian and endometrial cancer?
Genetic testing for ovarian and endometrial cancer is unique because it focuses on identifying genetic mutations that may increase cancer risk, rather than treating the cancer itself. This approach allows for early detection and personalized prevention strategies, which can be more effective than traditional treatments that only address the cancer after it has developed.12678
What data supports the idea that Genetic Testing for Ovarian and Endometrial Cancer is an effective treatment?
The available research shows that genetic testing for ovarian cancer can help make important treatment decisions early on. For example, one study found that when women with newly diagnosed ovarian cancer were quickly referred for genetic counseling, it helped reduce their stress, anxiety, and depression. Another study suggested that having gynecologic oncologists directly offer genetic testing could be more efficient than traditional methods. These findings indicate that genetic testing can be a valuable tool in managing ovarian cancer effectively.59101112
What data supports the effectiveness of genetic testing for ovarian and endometrial cancer?
Research shows that genetic testing at the time of ovarian cancer diagnosis can help guide treatment decisions and reduce patient stress, anxiety, and depression. Additionally, genetic testing can lead to earlier diagnosis and potentially more effective treatment for those with a family history of breast or ovarian cancer.59101112
Are You a Good Fit for This Trial?
This trial is for African American and Caucasian adults over 18 with a new diagnosis of ovarian, endometrial, fallopian tube, or primary peritoneal cancer. They must have had diagnostic surgery at AU Health Medical Center and be able to give informed consent in English. Adequate tumor tissue from the surgery must be available for testing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery/Biopsy
Surgery/biopsy will be performed to obtain ovarian and endometrial samples
Genetic Testing and Survey
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.
DNA Preparation and Testing
Tumor/blood DNA preparation and genetic testing
Results and Counseling
Genetic test results will be released and uploaded in the EMR. If positive, genetic counseling will be scheduled.
Follow-up
Participants are monitored for safety and effectiveness after genetic testing
What Are the Treatments Tested in This Trial?
Interventions
- Genetic Testing
- Survey Administration
Genetic Testing is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Augusta University
Lead Sponsor