NCT01943968

Brief Summary

The aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic sclerosis. We will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic sclerosis. The results obtained may help us diagnose these complications of systemic sclerosis and hopefully even monitor patient treatment.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

September 12, 2013

Last Update Submit

September 12, 2013

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Fibrin Enzyme Levels in Blood

    Patients will undergo blood tests before study and after six months to determine levels of lysyl oxidase, semaphorin 7a and 3a and thus determine severity of the disease (systemic sclerosis).

    Six months

Study Arms (1)

Systemic sclerosis patients

OTHER

Systemic sclerosis patients will have blood tested for fibrotic enzyme levels

Other: Blood test

Interventions

Blood testOTHER
Systemic sclerosis patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Systemic Sclerosis Patients
  • Written consent to participation in study

You may not qualify if:

  • Serious active medical condition
  • Other autoimmune rheumatic disease
  • Current or past allergic/inflammatory reaction
  • Liver disease
  • Pregnant or breastfeeding
  • Illegal drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Doron River, MD

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Zilber, MD

CONTACT

972-54-7870716karinazilber@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 17, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

IL(1)