Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT01119573
Collaborator
National Cancer Institute (NCI) (NIH)
100

Study Details

Study Description

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer.

Condition or Disease Intervention/Treatment Phase
  • Genetic: RNA analysis
  • Genetic: microarray analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis

Detailed Description

OBJECTIVES:
  • To identify microRNA expression patterns associated with lymph node metastasis in samples from patients with endometrial cancer.

OUTLINE: Banked tumor tissue specimens are analyzed for microRNA expression profiling by microarray analysis and reverse transcriptase-PCR assays.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Official Title:
Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer
Study Start Date :
May 1, 2010
Anticipated Primary Completion Date :
Jun 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Association between microRNA expression and lymph node metastasis []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Histologically confirmed endometrioid endometrial cancer

  • Stage IA, IB, IC, or IIIC disease

  • Any grade

  • Enrolled and evaluated on GOG-0210 Molecular Staging Study of Endometrial Cancer

  • Consented to allow their specimens and clinical data to be collected and stored for future research

  • Underwent complete surgical staging, including the following:

  • Hysterectomy

  • Bilateral oophorectomy

  • Washings as well as pelvic lymphadenectomy (sampling of four left and four right pelvic lymph nodes)

  • Para-aortic lymphadenectomy (sampling of one left and one right para-aortic lymph node)

  • Sufficient high-quality frozen primary tumor for testing with ≥ 75% tumor cellularity and ≤ 10% necrosis

PATIENT CHARACTERISTICS:
  • Not specified
PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gynecologic Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David S. Miller, MD, Simmons Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01119573
Other Study ID Numbers:
  • CDR0000672415
  • GOG-8014
First Posted:
May 7, 2010
Last Update Posted:
Jun 22, 2010
Last Verified:
May 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2010