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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. completion date
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


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
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