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Lysyl Oxidase, Semaphorin 7a and Semaphorin 3a in Patients With Systemic Sclerosis

Primary Purpose

Systemic Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood test
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Systemic Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Systemic Sclerosis Patients
  • Written consent to participation in study

Exclusion Criteria:

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

Sites / Locations

  • Bnai Zion Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Systemic sclerosis patients

Arm Description

Systemic sclerosis patients will have blood tested for fibrotic enzyme levels

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 12, 2013
Last Updated
September 12, 2013
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01943968
Brief Title
Lysyl Oxidase, Semaphorin 7a and Semaphorin 3a in Patients With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systemic sclerosis patients
Arm Type
Other
Arm Description
Systemic sclerosis patients will have blood tested for fibrotic enzyme levels
Intervention Type
Other
Intervention Name(s)
Blood test
Primary Outcome Measure Information:
Title
Fibrin Enzyme Levels in Blood
Description
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).
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Systemic Sclerosis Patients Written consent to participation in study Exclusion Criteria: Serious active medical condition Other autoimmune rheumatic disease Current or past allergic/inflammatory reaction Liver disease Pregnant or breastfeeding Illegal drug or alcohol abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karina Zilber, MD
Phone
972-54-7870716
Email
karinazilber@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doron River, MD
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karina Zilber, MD

12. IPD Sharing Statement

Learn more about this trial

Lysyl Oxidase, Semaphorin 7a and Semaphorin 3a in Patients With Systemic Sclerosis

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