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Prognostic Biomarkers in Patients With Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01208467
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : August 23, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment
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 Other: Laboratory Biomarker Analysis

Detailed Description:


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.

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Study Type : Observational
Estimated Enrollment : 2824 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer
Actual Study Start Date : September 2010
Actual Primary Completion Date : May 2014

Group/Cohort Intervention/treatment
Basic science (DNA analysis)
DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.
Other: Laboratory Biomarker Analysis
Correlative studies

Primary Outcome Measures :
  1. ATR mutation status [ Time Frame: 1 month ]
    Parametric and non-parametric statistical tests will be performed to evaluate the association between ATR mutation status and demographic and clinical data. Product-limit estimates according to Kaplan-Meier method will be calculated and difference between survival according to ATR mutation status will be assessed using a two sided log rank test. The predictive ability of the final model will be assessed using a concordance index (C-statistic).

  2. Microsatellite instability (MSI) [ Time Frame: 1 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with endometrial cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01208467

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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Israel Zighelboim Gynecologic Oncology Group
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Responsible Party: Gynecologic Oncology Group Identifier: NCT01208467    
Other Study ID Numbers: GOG-8017
NCI-2011-02870 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-8017 ( Other Identifier: Gynecologic Oncology Group )
GOG-8017 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases