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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01119573
First received: May 6, 2010
Last updated: June 17, 2010
Last verified: May 2010
  Purpose

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 Intervention
Endometrial Cancer
Genetic: RNA analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Association between microRNA expression and lymph node metastasis [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119573

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: David S. Miller, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01119573     History of Changes
Other Study ID Numbers: CDR0000672415, GOG-8014
Study First Received: May 6, 2010
Last Updated: June 17, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I endometrial carcinoma
stage III endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
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

ClinicalTrials.gov processed this record on April 23, 2014