Lysyl Oxidase, Semaphorin 7a and Semaphorin 3a in Patient... | NCT01943968

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

NCT01943968

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Sep 17, 2013Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Systemic Sclerosis

Interventions

Blood test

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Sep 12, 2013

First Submission Date that Met QC Criteria

Sep 12, 2013

First Posted Date

Sep 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2013

Last Update Posted Date

Sep 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systemic sclerosis patients	Other	Systemic sclerosis patients will have blood tested for fibrotic enzyme levels	Other: Blood test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Other		Systemic sclerosis patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karina Zilber, MD	Contact	972-54-7870716		karinazilber@gmail.com

Overall Officials

Name	Affiliation	Role
Doron River, MD	Bnai Zion Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bnai Zion Medical Center		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided