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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been newly diagnosed with ovarian, endometrial, fallopian tube, or primary peritoneal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Consent rate for germline testing

Secondary study objectives

Comparison of rate of Participation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met