Clinical trial NCT00250770: Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis
Official title: CSF-1 and Other Cytokines in Human Endometrial Carcinogenesis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Uterine Neoplasms
Endometrial Neoplasms
Keywords: Corpus Uteri
Endometrium
Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Harriet Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: