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

This study is currently recruiting participants.
Verified May 2016 by University of New Mexico
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250770
First Posted: November 8, 2005
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of New Mexico
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250770


Contacts
Contact: Suzanne Monroy 505-272-6665 smonroy@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Suzanne Monroy    505-272-6665    smonroy@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Harriet Smith, MD University of New Mexico
  More Information

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00250770     History of Changes
Other Study ID Numbers: CSF-1
First Submitted: November 4, 2005
First Posted: November 8, 2005
Last Update Posted: May 12, 2016
Last Verified: May 2016

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

Additional relevant MeSH terms:
Neoplasms
Endometrial Neoplasms
Carcinogenesis
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplastic Processes
Pathologic Processes