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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00250770
First received: November 4, 2005
Last updated: June 23, 2010
Last verified: July 2009
History of Changes
  Purpose

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.

Condition
Uterine Neoplasms
Endometrial Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: CSF-1 and Other Cytokines in Human Endometrial Carcinogenesis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 750
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)
Groups/Cohorts
1

Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma.

Women undergoing hysterectomy for benign conditions.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250770

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Harriet Smith, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Harriet Smith, MD; Principal Investigator, Universtiy of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00250770     History of Changes
Other Study ID Numbers: CSF-1
Study First Received: November 4, 2005
Last Updated: June 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Corpus Uteri
Endometrium
Cancer

Additional relevant MeSH terms:
Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Adenoma
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on June 18, 2013