Genetic Testing in African Americans
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.
Conditions:
🦠 Ovarian Cancer 🦠 Endometrial Cancer 🦠 Peritoneal Cancer
🗓️ Study Start (Actual) 20 April 2023
🗓️ Primary Completion (Estimated) November 2027
✅ Study Completion (Estimated) November 2027
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Augusta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age ≥ 18 years of age.
    • 2. New diagnosis of ovarian, endometrial, fallopian, or primary peritoneal carcinoma.
    • 3. Diagnostic procedure performed at AU Health Medical Center.
    • 4. 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.
    • 5. Consent at first post-biopsy outpatient clinic visit (typically about 2 weeks).
    • 6. Ability to provide informed consent in English.

    Exclusion Criteria:

    • There are no exclusion criteria
    • -
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 October 2022
  • First Submitted that Met QC Criteria 19 October 2022
  • First Posted 24 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 July 2023
  • Last Update Posted 21 July 2023
  • Last Verified July 2023