NCT05591131

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
17mo left

Started Apr 2023

Typical duration for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Apr 2023Nov 2027

First Submitted

Initial submission to the registry

October 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

4.5 years

First QC Date

October 19, 2022

Last Update Submit

February 20, 2025

Conditions

Ovarian CancerEndometrial CancerPeritoneal Cancer

Keywords

Black and African American HealthGenetic TestingOvarian CancerEndometrial CancerPeritoneal Cancer

Outcome Measures

Primary Outcomes (1)

  • Consent rate for germline testing

    Percentage of all patients with ovarian and endometrial cancer who complete testing

    12 months

Secondary Outcomes (1)

  • Comparison of rate of Participation

    12 months

Study Arms (1)

Study Time and Events Table

EXPERIMENTAL

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.

Other: genetic testingOther: Survey Administration

Interventions

genetic testingOTHER

Undergo genetic testing

Also known as: genetic analysis, Genetic Examination, Genetic Test
Study Time and Events Table
Survey AdministrationOTHER

Complete survey

Study Time and Events Table

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 24, 2022

Study Start

April 20, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)