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

NCT ID: NCT01198171

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

243 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Study of Socioeconomic and Demographic Variables

Intervention Type OTHER

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Study of Socioeconomic and Demographic Variables

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodney Rocconi

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-02867

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000684547

Identifier Type: -

Identifier Source: secondary_id

GOG-8022

Identifier Type: -

Identifier Source: secondary_id

GOG-8022

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-8022

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA134254

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA071754

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21CA133295

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA037517

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-8022

Identifier Type: -

Identifier Source: org_study_id

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