Prognostic Biomarkers in Patients With Endometrial Cancer

Endometrial Adenocarcinoma Clinical Trial

Official title:

Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208467
• Other study ID #: GOG-8017
• Secondary ID: NCI-2011-02870GO
• Status: Completed
• Phase: N/A
• First received: September 23, 2010
• Last updated: August 22, 2017
• Start date: September 2010

Study information

• Verified date: August 2017
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2824
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Endometrial Adenocarcinoma
• Endometrial Neoplasms
• Recurrent Uterine Corpus Carcinoma
• Stage I Uterine Corpus Cancer
• Stage II Uterine Corpus Cancer
• Stage III Uterine Corpus Cancer
• Stage IV Uterine Corpus Cancer
• Uterine Neoplasms

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ATR mutation status	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).	1 month
Primary	Microsatellite instability (MSI)		1 month