Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis

Sponsor

University of New Mexico (Other)

Overall Status

Unknown status

CT.gov ID

NCT00250770

Collaborator

(none)

750

Enrollment

Location

288

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Neoplasms Endometrial Neoplasms

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

CSF-1 and Other Cytokines in Human Endometrial Carcinogenesis

Study Start Date :

Jan 1, 1998

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
1 Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma. Women undergoing hysterectomy for benign conditions.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.