- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03268330
Role of Macrophage Migratory Inhibitory Factor in Systemic Sclerosis
January 11, 2021 updated by: Naima eid, Assiut University
Migration Inhibitory Factor has proliferative and antiapoptotic actions on fibroblasts which may be relevant to scleroderma because of the central role of a dysregulated fibroproliferative response in disease-affected tissues
Study Overview
Status
Unknown
Conditions
Detailed Description
- Systemic sclerosis (scleroderma) is a disease of unknown etiology characterized by fibrosis of the skin and internal organs, pronounced vasculopathy, and dysregulated immune system.
- Clinically, the disease is divided into 2 major subsets, diffuse cutaneous SSc (dcSSc) and limited cutaneous SSc (lcSSc). The diffuse cutaneous subtype is generally associated with significant internal organ involvement, especially renal crisis and diffuse alveolitis of the lung, along with antitopoisomerase (antitopo) autoantibody. The limited cutaneous subtype is distinguished by Raynaud's phenomenon, telangiectasias, pulmonary hypertension, and the presence of anticentromere antibody. However, there is significant overlap both in the clinical manifestations and in the specific autoantibodies that occur in these subtypes. It is not known what predisposes a susceptible individual to develop one subtype versus another, nor is there significant information about how the 2 disease subtypes may be pathogenically related.
- Activation of T lymphocytes and macrophages is an early event in the parthenogenesis of SSc. Activated T cells , macrophages and endothelial cells are important sources of Macrophage Migration Inhibitory Factor MIF was initially identified as the protein secreted by activated T lymphocytes capable of inhibiting random migration of macrophages, concentrating macrophages at inflammation loci, and enhancing their ability to kill intracellular parasites and tumoral cells.
- Migration Inhibitory Factor has proliferative and antiapoptotic actions on fibroblasts which may be relevant to scleroderma because of the central role of a dysregulated fibroproliferative response in disease-affected tissues.
- In patients with SSc, elevated serum levels of MIF, increased MIF expression in the skin and afunctional promoter polymorphism in the MIF gene that might influence clinical expression have been described therefore MIF might have an important role in the disease.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- Recruiting
- Assiut university hospital
-
Contact:
- Naima Omran
- Phone Number: 01008592039
- Email: heissa999@yahoo.com
-
Contact:
- Nihal Fathi
- Phone Number: 01005364739
- Email: Nfathy@yahoo.com
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Assuit, Egypt
- Recruiting
- Assuit University Hospital
-
Contact:
- Nihal Fathi
- Phone Number: 01005364739
- Email: Nfathy@yahoo.com
-
Contact:
- Naima Omran
- Email: heissa999@yahoo.com
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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
17 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
-Patients with Systemic Sclerosis diagnosed by Rheumatologists at Department of Rheumatology, Rehabilitation and Physical Medicine Assiut University.
Description
Inclusion Criteria:
-Patients with Systemic Sclerosis .
Exclusion Criteria:
- Patients with Interstitial Pulmonary Fibrosis caused by causes other than SSc.
- Other rheumatologic diseases.
- Overlap or Mixed diseases.
- Patients with renal disease caused by causes other than SSc.
- Unwillingness to participate in the study.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between Migration Inhibitory Factor and some of the clinical manifestations of Systemic Sclerosis.
Time Frame: 1 hour
|
Serum levels of Macrophage Migratory Inhibitory Factor will be measured by ELISA
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Doaa K Mohamed, Lectruer, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sakkas LI, Chikanza IC, Platsoucas CD. Mechanisms of Disease: the role of immune cells in the pathogenesis of systemic sclerosis. Nat Clin Pract Rheumatol. 2006 Dec;2(12):679-85. doi: 10.1038/ncprheum0346.
- Selvi E, Tripodi SA, Catenaccio M, Lorenzini S, Chindamo D, Manganelli S, Romagnoli R, Ietta F, Paulesu L, Miracco C, Cintorino M, Marcolongo R. Expression of macrophage migration inhibitory factor in diffuse systemic sclerosis. Ann Rheum Dis. 2003 May;62(5):460-4. doi: 10.1136/ard.62.5.460.
- Wu SP, Leng L, Feng Z, Liu N, Zhao H, McDonald C, Lee A, Arnett FC, Gregersen PK, Mayes MD, Bucala R. Macrophage migration inhibitory factor promoter polymorphisms and the clinical expression of scleroderma. Arthritis Rheum. 2006 Nov;54(11):3661-9. doi: 10.1002/art.22179.
- Mitchell RA, Metz CN, Peng T, Bucala R. Sustained mitogen-activated protein kinase (MAPK) and cytoplasmic phospholipase A2 activation by macrophage migration inhibitory factor (MIF). Regulatory role in cell proliferation and glucocorticoid action. J Biol Chem. 1999 Jun 18;274(25):18100-6. doi: 10.1074/jbc.274.25.18100.
- Calandra T, Bernhagen J, Mitchell RA, Bucala R. The macrophage is an important and previously unrecognized source of macrophage migration inhibitory factor. J Exp Med. 1994 Jun 1;179(6):1895-902. doi: 10.1084/jem.179.6.1895.
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 (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
August 29, 2017
First Submitted That Met QC Criteria
August 29, 2017
First Posted (Actual)
August 31, 2017
Study Record Updates
Last Update Posted (Actual)
January 12, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROMMIFISS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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