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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01119573
First Posted: May 7, 2010
Last Update Posted: June 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  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

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

Primary Outcome Measures:
  • Association between microRNA expression and lymph node metastasis

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119573


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

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01119573     History of Changes
Other Study ID Numbers: CDR0000672415
GOG-8014
First Submitted: May 6, 2010
First Posted: May 7, 2010
Last Update Posted: June 22, 2010
Last Verified: May 2010

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female