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

Primary Purpose

Endometrial Cancer

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
RNA analysis
microarray analysis
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Endometrial Cancer focused on measuring stage I endometrial carcinoma, stage III endometrial carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Association between microRNA expression and lymph node metastasis

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2010
    Last Updated
    June 17, 2010
    Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01119573
    Brief Title
    Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer
    Official Title
    Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    June 2010 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Cancer
    Keywords
    stage I endometrial carcinoma, stage III endometrial carcinoma

    7. Study Design

    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    RNA analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    microarray analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    reverse transcriptase-polymerase chain reaction
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Primary Outcome Measure Information:
    Title
    Association between microRNA expression and lymph node metastasis

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David S. Miller, MD
    Organizational Affiliation
    Simmons Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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