Prognostic Biomarkers in Patients With Endometrial Cancer

NCT ID: NCT01208467

Last Updated: 2017-08-23

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

2824 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Brief Summary

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This research study is studying prognostic biomarkers 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.

Detailed Description

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PRIMARY OBJECTIVES:

I. To validate the clinicopathologic associations and prognostic significance of ATR mutation in endometrioid endometrial cancer cases with defective DNA mismatch repair.

OUTLINE: This is a multicenter study.

DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.

Conditions

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Endometrial Adenocarcinoma Recurrent Uterine Corpus Carcinoma 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

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Basic science (DNA analysis)

DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women who were eligible and evaluable for the GOG-0210 molecular staging protocol in women with endometrial cancer

* Women who were registered during the unrestricted enrollment period (through 9/23/07) will automatically qualify
* Women who were registered during the restricted enrollment period (after 9/23/07) will only be considered if needed
* Women who had histologically confirmed endometrioid endometrial adenocarcinoma regardless of stage or grade
* Women who have defective DNA mismatch repair and are microsatellite instability positive (MSI+ and MSI-low)
* Women who consented to allow their specimens and clinical data to be used for future cancer research
* Women who have sufficient high-quality genomic DNA from tumor available for mutation analysis of ATR
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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Israel Zighelboim

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-2011-02870

Identifier Type: REGISTRY

Identifier Source: secondary_id

GOG-8017

Identifier Type: -

Identifier Source: secondary_id

CDR0000685834

Identifier Type: -

Identifier Source: secondary_id

GOG-8017

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-8017

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-8017

Identifier Type: -

Identifier Source: org_study_id

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