21 Participants Needed

Genetic Testing for Ovarian and Endometrial Cancer

(GTM-I Trial)

GC
AS
Overseen ByAshlyn Stevenson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Augusta University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

Consent at first post-biopsy outpatient clinic visit (typically about 2 weeks)
Diagnostic procedure performed at AU Health Medical Center
I have been newly diagnosed with ovarian, endometrial, fallopian tube, or primary peritoneal cancer.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Surgery/Biopsy

Surgery/biopsy will be performed to obtain ovarian and endometrial samples

1 day
1 visit (in-person)

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.

1 week
1 visit (in-person)

DNA Preparation and Testing

Tumor/blood DNA preparation and genetic testing

4 weeks

Results and Counseling

Genetic test results will be released and uploaded in the EMR. If positive, genetic counseling will be scheduled.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after genetic testing

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Genetic Testing
  • Survey Administration
Trial Overview The study tests genetic material from tumors and blood samples of patients after their cancer surgery to identify any genetic factors associated with these cancers. It aims to understand barriers faced by minorities in accessing such genetic testing.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Study Time and Events TableExperimental Treatment2 Interventions

Genetic Testing is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Genetic Testing for:
🇪🇺
Approved in European Union as Genetic Testing for:
🇨🇦
Approved in Canada as Genetic Testing for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials
219
Recruited
85,900+

Published Research Related to This Trial

A facilitated referral pathway for genetic counseling in newly-diagnosed ovarian cancer patients led to a high uptake, with 78 out of 100 patients receiving counseling and 73 undergoing genetic testing within a median of 34 days from diagnosis.
Despite initial stress and anxiety reported by patients during testing, quality of life improved significantly after 6 months, indicating that early genetic testing does not have a long-term negative psychological impact and is crucial for informing treatment decisions.
Facilitated referral pathway for genetic testing at the time of ovarian cancer diagnosis: uptake of genetic counseling and testing and impact on patient-reported stress, anxiety and depression.Frey, MK., Lee, SS., Gerber, D., et al.[2020]
All women diagnosed with epithelial ovarian cancer should undergo germline genetic testing for BRCA1/2 and other susceptibility genes to guide treatment options, based on a systematic review of 19 studies.
For women without germline BRCA1/2 variants, somatic tumor testing is recommended to identify any pathogenic variants, which can lead to FDA-approved treatment options, emphasizing the importance of personalized medicine in cancer care.
Germline and Somatic Tumor Testing in Epithelial Ovarian Cancer: ASCO Guideline.Konstantinopoulos, PA., Norquist, B., Lacchetti, C., et al.[2022]
A pilot study involving 40 women with newly diagnosed ovarian cancer showed that gynecologic oncologists directly offering genetic testing significantly increased the uptake of testing compared to traditional referral methods, where only 67% of patients completed testing.
The direct approach also reduced the time from diagnosis to receiving test results, with pilot participants receiving results in an average of 34 days compared to 53 days for those referred to genetics, indicating a more efficient process.
Streamlining genetic testing for women with ovarian cancer in a Northern California health care system.Powell, CB., Laurent, C., Ciaravino, G., et al.[2021]

Citations

Facilitated referral pathway for genetic testing at the time of ovarian cancer diagnosis: uptake of genetic counseling and testing and impact on patient-reported stress, anxiety and depression. [2020]
Germline and Somatic Tumor Testing in Epithelial Ovarian Cancer: ASCO Guideline. [2022]
Streamlining genetic testing for women with ovarian cancer in a Northern California health care system. [2021]
Genetic Testing and Results in a Population-Based Cohort of Breast Cancer Patients and Ovarian Cancer Patients. [2023]
[Genetic testing of BRCA1 for familial ovarian cancers]. [2006]
Acceptance of genetic counseling and testing in a hospital-based series of patients with gynecological cancer. [2021]
Improving attendance to genetic counselling services for gynaecological oncology patients. [2022]
Women's experiences of undergoing BRCA1 and BRCA2 testing: organisation of the German Hereditary Breast and Ovarian Cancer Consortium Survey and Preliminary Data from Münster. [2017]
Targeted Next-Generation Sequencing for Hereditary Cancer Syndromes: A Focus on Lynch Syndrome and Associated Endometrial Cancer. [2015]
An Integrated Approach for the Early Detection of Endometrial and Ovarian Cancers (Screenwide Study): Rationale, Study Design and Pilot Study. [2023]
Genetic screening for gynecological cancer: where are we heading? [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Testing for Hereditary Predisposition in Patients with Gynecologic Cancers, Quo Vadis? [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security