Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis
The purposes of this study are the following:
- To further characterize and quantify both CSF-1 and colony-stimulating factor-1 receptor (CSF-1R) expression from additional tumor specimens, specifically, tumors of high grade and from metastatic sites.
- To assay using Enzyme-Linked ImmunoSorbent Assay (ELISA) sandwich monoclonal antibody methodology, CSF-1 expression in the peritoneal fluid and blood from patients with endometrial adenocarcinomas.
- Using immunohistochemistry, to evaluate the presence of staining for CSF-1 and CSF-1R from additional patients with endometrial adenocarcinomas, especially of high grades and from metastatic sites.
- To determine the extent of cytokine, specifically CSF-1, but also interleukin-1 (IL-1), IL-6, and granulocyte-macrophage colony-stimulating factor (GM-CSF), production, in endometrial carcinoma cells in primary cell culture.
- To determine the responsiveness of epithelial cells on estrogen and antiestrogen binding, to determine if CSF-1 production is mediated, in these cells, by estrogen receptor binding, or alternative pathways of intracellular/cell-cell signal transduction.
- The ultimate objective of these experiments is to characterize CSF-1 expression from benign and tumor cells in order to identify steps in the CSF-1 activated signalling pathways that may represent potential targets for therapy.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||CSF-1 and Other Cytokines in Human Endometrial Carcinogenesis|
We have collected serum and ascites from approximately 200 patients with endometrial carcinoma and 200 controls. We have long term follow-up serum from approximately 60 of these patients. Approximately 10% of endometrial carcinoma patients recur. Our goal will be to eventually have follow-up serum from up to 60 patients with recurrent endometrial carcinoma in our tissue bank, so that we can determine the role of these assays in predicting recurrence.
|Study Start Date:||January 1998|
|Estimated Study Completion Date:||January 2022|
|Estimated Primary Completion Date:||January 2022 (Final data collection date for primary outcome measure)|
Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma.
Women undergoing hysterectomy for benign conditions.
These experiments, taken together, should critically determine if there is a role for the CSF-1/ c-fms autocrine, endocrine, or paracrine loop in the progression of endometrial adenocarcinoma. If so, alterations in this loop may provide novel medical therapies for this disease. Additionally, these experiments will determine which are the predominant cytokines expressed in these tumors, and will help the investigators to determine the role, if any, these cytokines play in cancer cell growth and proliferation in relationship with each other and within and outside of the estrogen-mediated pathways.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250770
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Harriet Smith, MD||University of New Mexico|