System; SclerosisNCT03268330
Role of Macrophage Migratory Inhibitory Factor in Systemic Sclerosis
An observational study of System; Sclerosis, run by Assiut University at 2 sites in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- System; Sclerosis
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- Sep 2021to Nov 2021
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: -Patients with Systemic Sclerosis diagnosed by Rheumatologists at Department of Rheumatology, Rehabilitation and Physical Medicine Assiut University.
Who may be able to join
- -Patients with Systemic Sclerosis .
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Assiut University Hospital
Asyut
Naima Omran, 01008592039, heissa999@yahoo.com
Nihal Fathi, 01005364739, Nfathy@yahoo.com
- Recruiting
Assuit University hospital
Asyut
Naima Omran, heissa999@yahoo.com
Nihal Fathi, 01005364739, Nfathy@yahoo.com
About this study
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
Read the 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.
- Conditions
- System; Sclerosis
- Medical subject headings
- Scleroderma, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Migration Inhibitory Factor and some of the clinical manifestations of Systemic Sclerosis.
Serum levels of Macrophage Migratory Inhibitory Factor will be measured by ELISA
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startSep 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for System; SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naima eid, Assiut University
- Investigators
- Doaa K Mohamed, Lectruer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268330
- Sponsor's protocol ID
- ROMMIFISS
- Status last verified
- Jan 2021
- First submitted
- 29 Aug 2017
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 17133253Selvi 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.
PubMed 12695161Wu 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.
PubMed 17075815Mitchell 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.
PubMed 10364264Calandra 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.
PubMed 8195715
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Macrophage Migratory Inhibitory Factor in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03268330
- Acronym / sponsor ID
- ROMMIFISS
- Conditions
- System; Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 31 Aug 2017 (actual)
- 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -Patients with Systemic Sclerosis diagnosed by Rheumatologists at Department of Rheumatology, Rehabilitation and Physical Medicine Assiut University.
Key inclusion criteria (1 listed)
- -Patients with Systemic Sclerosis .
Key exclusion criteria (5 listed)
- 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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 17133253Sakkas 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.
- Background: PubMed 12695161Selvi 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.
- Background: PubMed 17075815Wu 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.
- Background: PubMed 10364264Mitchell 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.
- Background: PubMed 8195715Calandra 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.
- Individual participant dataSharing planned: Undecided
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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.
Doaa K Mohamed, Lectruer study director
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of System; Sclerosis, run by Assiut University at 2 sites in Egypt.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naima M Omran, Resident (+01008592039, heissa999@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Migration Inhibitory Factor and some of the clinical manifestations of Systemic Sclerosis. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268330, which also lists 5 linked publications.
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 12 Jan 2021.