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OpenTrials
Completed

NCT Number: NCT01198171

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

study of socioeconomic and demographic variables

Other

Primary outcomes

  1. 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

  2. Overall survival

    Time frame: 1 year

  3. Progression-free survival

    Time frame: 1 year

  4. Proportion of genetic background that is of African-American descent

    Time frame: 1 year

Secondary outcomes

  1. Racial genetic admixture score, summarized by race and other clinicopathologic variables

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2010
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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