Uterine NeoplasmsNCT00250770
Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis
An observational study of Uterine Neoplasms and Endometrial Neoplasms, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Neoplasms, Endometrial Neoplasms
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Jan 1999
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who do not have primary uterine corpus tumors.
- Patients with less than one gram of tumor tissue available to procurement.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterine Neoplasms, Endometrial Neoplasms
- Keywords
- Corpus Uteri, Endometrium, Cancer
- Medical subject headings
- Uterine Neoplasms, Endometrial Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma. Women undergoing hysterectomy for benign conditions. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startJan 1998
- Primary completionJan 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harriet Smith, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250770
- Sponsor's protocol ID
- CSF-1
- Status last verified
- Jun 2023
- First submitted
- 4 Nov 2005
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSF-1 and Other Cytokines in Human Endometrial Carcinogenesis
- ClinicalTrials.gov ID
- NCT00250770
- Acronym / sponsor ID
- CSF-1
- Conditions
- Uterine Neoplasms, Endometrial Neoplasms
- Keywords
- Corpus Uteri, Endometrium, Cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Jan 1999 (actual)
- First posted
- 8 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma. Women undergoing hysterectomy for benign conditions. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who do not have primary uterine corpus tumors.
- Patients with less than one gram of tumor tissue available to procurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harriet Smith, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Neoplasms and Endometrial Neoplasms, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.