The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gynecologic Oncology Group
- Enrollment
- 243
- Locations
- 1
- Primary Endpoint
- Progression-free survival
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 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
Overall survival
Time Frame: 1 year
Proportion of genetic background that is of African-American descent
Time Frame: 1 year
Secondary Outcomes
- Racial genetic admixture score, summarized by race and other clinicopathologic variables(1 year)