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Genetic Testing
Genetic Testing for Ovarian and Endometrial Cancer (GTM-I Trial)
N/A
Recruiting
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years of age
New diagnosis of ovarian, endometrial, fallopian, or primary peritoneal carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
GTM-I Trial Summary
This trial aims to sequence cancer genes in tumor/blood samples from African American & Caucasian patients with ovarian/endometrial cancer to identify minority barriers & provide direct clinical value to patients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves only genetic testing and survey administration rather than drug treatments, there are no direct side effects related to medications; however, some individuals may experience anxiety or emotional distress related to learning about their genetic risks.
GTM-I Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been newly diagnosed with ovarian, endometrial, fallopian tube, or primary peritoneal cancer.
GTM-I Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Consent rate for germline testing
Secondary outcome measures
Comparison of rate of Participation
GTM-I Trial Design
1Treatment groups
Experimental Treatment
Group I: Study Time and Events TableExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
85,038 Total Patients Enrolled
1 Trials studying Ovarian Cancer
438 Patients Enrolled for Ovarian Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have been newly diagnosed with ovarian, endometrial, fallopian tube, or primary peritoneal cancer.I have enough tissue from a biopsy for tumor testing.
Research Study Groups:
This trial has the following groups:- Group 1: Study Time and Events Table
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently opportunities to join this research endeavor?
"Contrary to what was expected, clinicaltrials.gov states that this medical research is not currently taking on new participants. The trial began recruiting on the 1st of November 2022 and had its last update on October 27th 2022. However, there are 861 other trials actively enrolling patients at present moment in time."
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