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

The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01198171
Enrollment
243
Registered
2010-09-09
Start date
2010-01-31
Completion date
2017-02-28
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERLaboratory Biomarker Analysis

Correlative studies

OTHERStudy of Socioeconomic and Demographic Variables

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime 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 metastasis1 year
Overall survival1 year
Progression-free survival1 year
Proportion of genetic background that is of African-American descent1 year

Secondary

MeasureTime frame
Racial genetic admixture score, summarized by race and other clinicopathologic variables1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026