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Prognostic Biomarkers in Patients With Endometrial Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01208467
Enrollment
2824
Registered
2010-09-24
Start date
2010-09-30
Completion date
Unknown
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERLaboratory Biomarker Analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ATR mutation status1 monthParametric 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026