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

The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Stage I Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Study of Socioeconomic and Demographic Variables

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 Type: Observational
• Enrollment (Actual): 243

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Gynecologic Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with endometrial cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Basic science (DNA 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Study of Socioeconomic and Demographic Variables

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rodney Rocconi, Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: September 8, 2010
• First Submitted That Met QC Criteria: September 8, 2010
• First Posted (Estimated): September 9, 2010

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: GOG-8022 (Other Identifier: CTEP); U10CA027469 (U.S. NIH Grant/Contract); NCI-2011-02867 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CDR0000684547; P50CA134254 (U.S. NIH Grant/Contract); R01CA071754 (U.S. NIH Grant/Contract); R21CA133295 (U.S. NIH Grant/Contract); U10CA037517 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No