Racial and Genetic Biomarkers of Response in Tissue Samples From Patients With Endometrial Cancer

Completed

• Conditions: Stage I Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer; Stage III Uterine Corpus Cancer
• Interventions: Other: Laboratory Biomarker Analysis; Other: Study of Socioeconomic and Demographic Variables

• Registration Number: NCT01198171
• Lead Sponsor: Gynecologic Oncology Group

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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 243

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basic science (DNA analysis)	Laboratory Biomarker 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.
Basic science (DNA analysis)	Study of Socioeconomic and Demographic Variables	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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	1 year
Overall survival	1 year
Proportion of genetic background that is of African-American descent	1 year

Secondary Outcome Measures

Name	Time	Method
Racial genetic admixture score, summarized by race and other clinicopathologic variables	1 year

Trial Locations

Locations (1)

Gynecologic Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States