Racial and Genetic Biomarkers of Response in Tissue Samples From Patients With Endometrial Cancer
August 12, 2024 updated by: Gynecologic Oncology Group
The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes
This research study is studying racial and genetic biomarkers of response in tissue samples from patients with endometrial cancer.
Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
DNA analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To identify racial categorization as the proportion of genetic background of African-American or European-American women with endometrioid endometrial cancer (EEC).
II. To evaluate the association of racial genetic admixture with clinicopathologic variables and outcomes.
SECONDARY OBJECTIVES:
I. To compare the concordance between racial genetic admixture and self-designated race categorization.
OUTLINE: This is a multicenter study. Patients are stratified by race (African-American vs European-American) and disease stage (I vs II vs III vs IV).
DNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers. Clinicopathological and demographic characteristics associated with each sample are also collected.
Study Type
Observational
Enrollment (Actual)
243
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patient with endometrial cancer
Description
Inclusion Criteria:
Histologically confirmed endometrial cancer
- Stage I-IV disease regardless of grade
- Underwent surgical staging including hysterectomy, bilateral oophorectomy, washings, and pelvic lymphadenectomy
- Eligible and evaluated on GOG-0210 clinical trial, a Molecular Staging Study in Endometrial Cancer
- Available frozen or formalin-fixed and paraffin-embedded normal tissue that is free of tumor cells and yields sufficient high-quality normal DNA for testing
- Consented their specimens and clinical data to be collected and used in future studies
- Self-declared African-American or Caucasian race
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Basic science (DNA analysis)
DNA from archived frozen normal tissue samples is genotyped for the ancestry informative markers.
Clinicopathological and demographic characteristics associated with each sample are also collected.
|
Correlative studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 1 year
|
1 year
|
|
Clinicopathologic and demographic characteristics: characteristics: self-reported race, stage, age, race, parity, body-mass index, stage, grade, depth of invasion, lymph-vascular space invasion, and metastasis
Time Frame: 1 year
|
1 year
|
|
Progression-free survival
Time Frame: 1 year
|
1 year
|
|
Proportion of genetic background that is of African-American descent
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Racial genetic admixture score, summarized by race and other clinicopathologic variables
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rodney Rocconi, Gynecologic Oncology Group
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 Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
September 8, 2010
First Submitted That Met QC Criteria
September 8, 2010
First Posted (Estimated)
September 9, 2010
Study Record Updates
Last Update Posted (Actual)
August 14, 2024
Last Update Submitted That Met QC Criteria
August 12, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOG-8022 (Other Identifier: CTEP)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2011-02867 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000684547
- P50CA134254 (U.S. NIH Grant/Contract)
- R01CA071754 (U.S. NIH Grant/Contract)
- R21CA133295 (U.S. NIH Grant/Contract)
- U10CA037517 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.