- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00250770
Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis
June 30, 2023 updated by: University of New Mexico
CSF-1 and Other Cytokines in Human Endometrial Carcinogenesis
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.
Study Overview
Status
Withdrawn
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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Suzanne Monroy
- Phone Number: 505-272-6665
- Email: smonroy@salud.unm.edu
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma. Women undergoing hysterectomy for benign conditions. |
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harriet Smith, MD, University of New Mexico
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1998
Primary Completion (Actual)
January 1, 1999
Study Completion
January 1, 2022
Study Registration Dates
First Submitted
November 4, 2005
First Submitted That Met QC Criteria
November 4, 2005
First Posted (Estimated)
November 8, 2005
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
June 30, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Uterine Diseases
- Neoplastic Processes
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Neoplasms
- Endometrial Neoplasms
- Carcinogenesis
- Uterine Neoplasms
Other Study ID Numbers
- CSF-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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