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

Stage II Uterine Corpus Cancer Clinical Trial

Official title:

The Relationship of Racial Genetic Admixture With Endometrial Cancer Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01198171
• Other study ID #: GOG-8022
• Secondary ID: NCI-2011-02867CD
• Status: Not yet recruiting
• Phase: N/A
• First received: September 8, 2010
• Last updated: May 27, 2015
• Start date: January 2100

Study information

• Verified date: May 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 243
• Est. primary completion date: January 2100
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Stage I Uterine Corpus Cancer
• Stage II Uterine Corpus Cancer
• Stage III Uterine Corpus Cancer
• Stage IV Uterine Corpus Cancer
• Uterine Neoplasms

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Study of Socioeconomic and Demographic Variables

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Overall survival		1 year	No
Primary	Progression-free survival		1 year	No
Primary	Proportion of genetic background that is of African-American descent		1 year	No
Secondary	Racial genetic admixture score, summarized by race and other clinicopathologic variables		1 year	No