Prognostic Biomarkers in Patients With Endometrial Cancer
Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer
4 other identifiers
observational
2,824
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 23, 2010
CompletedFirst Posted
Study publicly available on registry
September 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedAugust 23, 2017
August 1, 2017
3.7 years
September 23, 2010
August 22, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Microsatellite instability (MSI)
1 month
Study Arms (1)
Basic science (DNA analysis)
DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.
Interventions
Eligibility Criteria
Patients with endometrial cancer
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Israel Zighelboim
Gynecologic Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2010
First Posted
September 24, 2010
Study Start
September 1, 2010
Primary Completion
May 1, 2014
Last Updated
August 23, 2017
Record last verified: 2017-08