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Prognostic Biomarkers in Patients With Endometrial Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01208467
First received: September 23, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 23, 2010
September 23, 2010
October 2010
November 2010   (final data collection date for primary outcome measure)
  • Overall survival [ Designated as safety issue: No ]
  • Cancer-specific survival [ Designated as safety issue: No ]
Same as current
No Changes Posted
Disease-free survival [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prognostic Biomarkers in Patients With Endometrial Cancer
Validating the Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer

RATIONALE: 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.

PURPOSE: This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer.

OBJECTIVES:

Primary

  • 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.
Observational
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Endometrial Cancer
  • Genetic: DNA analysis
  • Genetic: mutation analysis
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
2824
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November 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Female
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No
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NCT01208467
CDR0000685834, GOG-8017
Not Provided
Philip J. DiSaia, Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Israel Zighelboim, MD Washington University Siteman Cancer Center
National Cancer Institute (NCI)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP