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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes

Conditions
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Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer

Intervention / Treatment
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* Other: Laboratory Biomarker Analysis
* Other: Study of Socioeconomic and Demographic Variables


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic science (DNA analysis)<br>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. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Study of Socioeconomic and Demographic Variables<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Progression-free survival |  | 1 year | 
| Proportion of genetic background that is of African-American descent |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Racial genetic admixture score, summarized by race and other clinicopathologic variables |  | 1 year |