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
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01208467
First received: September 23, 2010
Last updated: June 3, 2015
Last verified: June 2015
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • ATR mutation status [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with endometrial cancer

Criteria

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 ClinicalTrials.gov identifier: NCT01208467

Locations
United States, Pennsylvania
Gynecologic Oncology Group Active, not recruiting
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Israel Zighelboim Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01208467     History of Changes
Other Study ID Numbers: GOG-8017, NCI-2011-02870, GOG-8017, CDR0000685834, GOG-8017, GOG-8017, U10CA027469
Study First Received: September 23, 2010
Last Updated: June 3, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Uterine Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Diseases

ClinicalTrials.gov processed this record on August 27, 2015