NCT03268330

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
4 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

August 29, 2017

Last Update Submit

January 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 hour

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

-Patients with Systemic Sclerosis diagnosed by Rheumatologists at Department of Rheumatology, Rehabilitation and Physical Medicine Assiut University.

You may qualify if:

  • Patients with Systemic Sclerosis .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assiut University Hospital

Asyut, Egypt

RECRUITING

Assuit University hospital

Asyut, Egypt

RECRUITING

Related Publications (5)

  • 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.

    PMID: 17133253BACKGROUND
  • 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.

    PMID: 12695161BACKGROUND
  • 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.

    PMID: 17075815BACKGROUND
  • 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.

    PMID: 10364264BACKGROUND
  • 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.

    PMID: 8195715BACKGROUND

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Doaa K Mohamed, Lectruer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Naima M Omran, Resident

CONTACT

Nihal A Fathi, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 31, 2017

Study Start

September 1, 2021

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations