- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01208467
Prognostic Biomarkers in Patients With Endometrial Cancer
Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Basic science (DNA analysis)
DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.
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Correlative studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ATR mutation status
Time Frame: 1 month
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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).
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1 month
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Microsatellite instability (MSI)
Time Frame: 1 month
|
1 month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Israel Zighelboim, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOG-8017 (Other Identifier: CTEP)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2011-02870 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000685834
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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