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

NCT00250770 | Withdrawn DMC

• 1 other identifier: CSF-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are the following:

1. 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. 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. 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. 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. 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. 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.

Conditions

Uterine Neoplasms; Endometrial Neoplasms

Keywords

Corpus Uteri; Endometrium; Cancer

Study Arms (1)

1

Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma. Women undergoing hysterectomy for benign conditions.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not have primary uterine corpus tumors.
• Patients with less than one gram of tumor tissue available to procurement.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

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.

MeSH Terms

Conditions

Uterine Neoplasms; Endometrial Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Harriet Smith, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 8, 2005
• Study Start: January 1, 1998
• Primary Completion: January 1, 1999
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

US (1)