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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

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ClinicalTrials.gov Identifier: NCT01150682
Recruitment Status : Unknown
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 25, 2010
Last Update Posted : April 29, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment
Endometrial Cancer Genetic: RNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: enzyme-linked immunosorbent assay Other: immunohistochemistry staining method Other: laboratory biomarker analysis

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.

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Study Type : Observational
Estimated Enrollment : 865 participants
Official Title: Role of Sex Hormone and Insulin/IGF Axes in Endometrial Cancer Recurrence
Study Start Date : July 2010
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Patient characteristics: age, BMI, performance status, race, ethnicity
  2. Tumor characteristics
  3. Surgical compliance and type of surgical adjuvant therapy
  4. Overall survival
  5. Recurrence-free survival
  6. Site of first recurrence
  7. Biomarker values and expression levels


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT01150682


Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Marc Gunter, PhD Albert Einstein College of Medicine
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Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01150682    
Other Study ID Numbers: CDR0000680598
GOG-8015
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: August 2010
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Endometrial Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases