Clinical trial · Observational
Prognostic Biomarkers in Patients With Endometrial Cancer
Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer
NCT01208467CI-TRIAL-00029227completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Recurrent Uterine Corpus Carcinoma | — | UNRESOLVED | — |
| Stage III Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Basic science (DNA analysis)
- description
- DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.
- interventionNames
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- ATR mutation status
- timeFrame
- 1 month
- description
- 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).
- measure
- Microsatellite instability (MSI)
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.