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
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|
- 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.
|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|
- 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
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
|Principal Investigator:||Marc Gunter, PhD||Albert Einstein College of Medicine|