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Prognostic Biomarkers in Patients With Endometrial Cancer

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2015 by Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group Identifier:
First received: September 23, 2010
Last updated: June 3, 2015
Last verified: June 2015
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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer

Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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).

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

Estimated Enrollment: 2824
Study Start Date: January 2100
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01208467

United States, Pennsylvania
Gynecologic Oncology Group Active, not recruiting
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Israel Zighelboim Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group Identifier: NCT01208467     History of Changes
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 )
Study First Received: September 23, 2010
Last Updated: June 3, 2015

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female processed this record on August 21, 2017