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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
  Purpose

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.


Condition Intervention
Endometrial Cancer
 Genetic: DNA analysis
Genetic: mutation analysis
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Validating the Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Cancer-specific survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 2824
Study Start Date: October 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208467

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Israel Zighelboim, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01208467     History of Changes
Other Study ID Numbers: CDR0000685834, GOG-8017
Study First Received: September 23, 2010
Last Updated: September 23, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
endometrial adenocarcinoma
recurrent endometrial carcinoma
stage I endometrial carcinoma
 stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on June 17, 2013