Overview

This trial is active, not recruiting.

Condition endometrial cancer
Treatments rna analysis, reverse transcriptase-polymerase chain reaction, enzyme-linked immunosorbent assay, immunohistochemistry staining method, laboratory biomarker analysis
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date July 2010
End date July 2015
Trial size 865 participants
Trial identifier NCT01150682, CDR0000680598, GOG-8015

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

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

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Role of Sex Hormone and Insulin/IGF Axes in Endometrial Cancer Recurrence
Principal investigator Marc Gunter, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).
Location data was received from the National Cancer Institute and was last updated in June 2016.