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

Gynecologic Oncology Group (GOG)

Status: Completed

Conditions: Stage I Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage III Uterine Corpus Cancer

Treatments: Other: Laboratory Biomarker Analysis; Other: Study of Socioeconomic and Demographic Variables

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01198171

U10CA027469 (U.S. NIH Grant/Contract)

R21CA133295 (U.S. NIH Grant/Contract)

NCI-2011-02867 (Registry Identifier)

U10CA037517 (U.S. NIH Grant/Contract)

P50CA134254 (U.S. NIH Grant/Contract)

CDR0000684547

GOG-8022

R01CA071754 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 243 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

243 participants in 1 patient group

Basic science (DNA analysis)

Description:

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.

Treatment:

Other: Study of Socioeconomic and Demographic Variables

Other: Laboratory Biomarker Analysis