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Role of Biomarkers in Endometrial Cancer Recurrence in Samples From Patients With Stage II, Stage III, or Stage IV Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
RNA analysis
reverse transcriptase-polymerase chain reaction
enzyme-linked immunosorbent assay
immunohistochemistry staining method
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 endometrial adenocarcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenosquamous cell carcinoma, endometrial clear cell carcinoma, endometrial papillary serous carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrioid endometrial cancer

    • Stage II-IV disease
  • Patients who were eligible and evaluated on the GOG-0210, Molecular Staging in Endometrial Cancer clinical trial, meeting the following criteria:

    • Allowed their specimens and clinical data collected as part of their participation
    • Have sufficient high-quality frozen primary tumor, formalin-fixed and paraffin-embedded (FFPE) primary tumor, and/or pre-operative serum for testing available
  • Patients who underwent surgical staging as specified in the GOG-0210 protocol and described in the GOG Surgical Manual Protocol, including any of the following procedures:

    • Hysterectomy
    • Bilateral oophorectomy
    • Washings as well as pelvic lymphadenectomy and para-aortic lymphadenectomy
  • Non-cancerous endometrial tissue and fasting serum from control samples meeting the following criteria (controls):

    • Underwent hysterectomy to treat uterine prolapse at the Albert Einstein Hospital and Montefiore Medical Center, in the Bronx, NY
    • No uterine fibroids or prior cancer

PATIENT CHARACTERISTICS:

  • Postmenopausal patients and controls

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Patient characteristics: age, BMI, performance status, race, ethnicity
    Tumor characteristics
    Surgical compliance and type of surgical adjuvant therapy
    Overall survival
    Recurrence-free survival
    Site of first recurrence
    Biomarker values and expression levels

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2010
    Last Updated
    April 28, 2011
    Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01150682
    Brief Title
    Role of Biomarkers in Endometrial Cancer Recurrence in Samples From Patients With Stage II, Stage III, or Stage IV Endometrial Cancer
    Official Title
    Role of Sex Hormone and Insulin/IGF Axes in Endometrial Cancer Recurrence
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    July 2015 (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 blood and 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 the role of biomarkers in endometrial cancer recurrence in samples from patients with stage II, stage III, or stage IV endometrial cancer.
    Detailed Description
    OBJECTIVES: To investigate the association of endometrioid adenocarcinoma (EA) recurrence with pre-operative serum levels of insulin, total and free insulin-like growth factor-I (IGF-I), IGF-II, insulin-like growth factor-binding protein-1 (IGFBP-1) and IGFB-3, estradiol, estrone, progesterone, and sex hormone-binding globulin (SHBG) in samples from patients with stage II-IV endometrial cancer evaluated on GOG-0210. To study the associations of EA recurrence with pre-treatment tumor expression of IGF-I, IGF-II, and IGFBP-1 and -3 mRNA in samples from these patients. To study the associations of EA recurrence with pre-treatment tumor expression of insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor in samples from these patients. To measure the correlations of serum (protein) and tissue (mRNA) levels of IGF-I, IGF-II, and IGFBP-1 and -3 from samples of patients with EA and participants without cancer. OUTLINE: Banked serum and tumor tissues samples are analyzed for levels of insulin, total and free insulin-like growth factor (IGF-I), IGF-II, IGFBP-1 and IGFBP-3, estradiol, estrone, progesterone and sex hormone-binding globulin (SHBG); expression of IGF-I, IGF-II, IGFBP-1 and IGFBP -3 mRNA; and expression of the insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor by RT-PCR, IHC, and ELISA. Banked non-cancerous endometrial tissue and fasting serum samples from controls are also analyzed for IGF-I, IGF-II, IGFBP-1, and IGFBP-3 and compared with the results of endometrial adenocarcinoma (EA) samples. Clinical information associated with each EA samples (i.e., age, BMI, performance status, race, ethnicity, tumor stage, size, histology and grade, surgical compliance and type of post surgical adjuvant therapy, overall survival, recurrence-free survival, site of first recurrence, and biomarker values and expression) is also collected. PROJECTED ACCRUAL: A total of 815 patient specimens and 50 control specimens will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Cancer
    Keywords
    endometrial adenocarcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenosquamous cell carcinoma, endometrial clear cell carcinoma, endometrial papillary serous carcinoma

    7. Study Design

    Enrollment
    865 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    RNA analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    reverse transcriptase-polymerase chain reaction
    Intervention Type
    Other
    Intervention Name(s)
    enzyme-linked immunosorbent assay
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Primary Outcome Measure Information:
    Title
    Patient characteristics: age, BMI, performance status, race, ethnicity
    Title
    Tumor characteristics
    Title
    Surgical compliance and type of surgical adjuvant therapy
    Title
    Overall survival
    Title
    Recurrence-free survival
    Title
    Site of first recurrence
    Title
    Biomarker values and expression levels

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed endometrioid endometrial cancer Stage II-IV disease Patients who were eligible and evaluated on the GOG-0210, Molecular Staging in Endometrial Cancer clinical trial, meeting the following criteria: Allowed their specimens and clinical data collected as part of their participation Have sufficient high-quality frozen primary tumor, formalin-fixed and paraffin-embedded (FFPE) primary tumor, and/or pre-operative serum for testing available Patients who underwent surgical staging as specified in the GOG-0210 protocol and described in the GOG Surgical Manual Protocol, including any of the following procedures: Hysterectomy Bilateral oophorectomy Washings as well as pelvic lymphadenectomy and para-aortic lymphadenectomy Non-cancerous endometrial tissue and fasting serum from control samples meeting the following criteria (controls): Underwent hysterectomy to treat uterine prolapse at the Albert Einstein Hospital and Montefiore Medical Center, in the Bronx, NY No uterine fibroids or prior cancer PATIENT CHARACTERISTICS: Postmenopausal patients and controls PRIOR CONCURRENT THERAPY: See Disease Characteristics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marc Gunter, PhD
    Organizational Affiliation
    Albert Einstein College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Role of Biomarkers in Endometrial Cancer Recurrence in Samples From Patients With Stage II, Stage III, or Stage IV Endometrial Cancer

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