Prognostic Biomarkers in Patients With Endometrial Cancer

Completed

• Conditions: Stage II Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer; Stage I Uterine Corpus Cancer; Stage III Uterine Corpus Cancer; Recurrent Uterine Corpus Carcinoma; Endometrial Adenocarcinoma
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT01208467
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-24
• Primary Completion: 2014-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2824

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basic science (DNA analysis)	Laboratory Biomarker Analysis	DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.

Primary Outcome Measures

Name	Time	Method
ATR mutation status	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)	1 month

Trial Locations

Locations (1)

Gynecologic Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States