Overview

This trial is active, not recruiting.

Conditions uterine neoplasms, endometrial neoplasms
Sponsor University of New Mexico
Start date January 1998
End date January 2022
Trial size 750 participants
Trial identifier NCT00250770, CSF-1

Summary

The purposes of this study are the following:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma. Women undergoing hysterectomy for benign conditions.

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - All patients undergoing hysterectomy, or who have endometrial cancer, and are under routine surveillance. - Patients may have received prior hormonal, cytotoxic chemotherapy, irradiation or surgical therapy. - Healthy post-menopausal and peri-menopausal women. - A consent form must be signed by the patient prior to study entry. Exclusion Criteria: - Patients who do not have primary uterine corpus tumors. - Patients with less than one gram of tumor tissue available to procurement.

Additional Information

Official title CSF-1 and Other Cytokines in Human Endometrial Carcinogenesis
Principal investigator Harriet Smith, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of New Mexico.