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NVC Test in Order to Assess Pathological Changes in Family Members of Patient Diagnosed With SSc (SSc NVC)

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ClinicalTrials.gov Identifier: NCT02795221
Recruitment Status : Unknown
Verified June 2016 by yair levy, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
yair levy, Meir Medical Center

Tracking Information
First Submitted Date June 5, 2016
First Posted Date June 10, 2016
Last Update Posted Date June 10, 2016
Study Start Date June 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2016)
The Prevalence of abnormal nailfold capillaroscopy on First Grade Family relatives of patients with Systemic sclerosis [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NVC Test in Order to Assess Pathological Changes in Family Members of Patient Diagnosed With SSc
Official Title Observative and Community Study, Using Nailfold Video-capillaroscopy in Order to Assess the Prevalence of Pathological Changes in the Capillaries in First Grade Family Members of Patient Diagnosed With Systemic Sclerosis
Brief Summary

Systemic sclerosis (SSc) is multisystem autoimmune disease of unknown etiology. It's characterized by activation of immune system, microvascular changes and intimal proliferation.

The EULAR/ACR 2013 criteria for the classification of SSc will help identify SSC patients before fibrosis of internal organs and will allow early treatment.

Patient with RP, SSc-related autoAb, anti-topoisomerase I (SCL-70), anti-centromere autoAb, anti-RNApolymerase III, abnormal nailfold capillaries and puffy hands would have SSc.

The OR of abnormal capillaroscopy for subsequent development of SSc can reach 163 with positive predictive value of 52% and negative predictive value of 99% .Some studies found that preclinical internal organ involvement in pre-scleroderma patients, DLCO<80% was detected in 11/32 patients with RP plus SSc-associated autoAb plus SSc-type nailfold capillary changes.

The heritability of SSc was considered controversial in the, largest published SSc .Twin study, which in general suggested a modest genetic contribution to the Phenotype .Nevertheless, this study included only 42 sets of twins, and it should Be considered that, in a family study of 703 cases, an affected first-degree relative Increased the risk of SSc 13 times compared to the general population . Moreover, having an affected sibling increased SSc risk by 15 times , and there Was a remarkable concordance of auto antibodies between SSc twins . Additionally, recent analyses have shown that the standardized incidence ratio of SSc seemed to be less than those observed in autoimmune diseases (ADs) such as Rheumatoid arthritis or Ankylosing Spondylitis, but similar to those observed for Hashimoto, thyroiditis or psoriasis. In addition, SSc prevalence, clinical Outcomes and autoantibody profiles have been reported to vary depending on Patient ancestry Therefore, the role of genetic factors in SSc susceptibility can now be considered solidly established.

A positive family history of SSc appears to confer a risk that is at least 10-16-fold Higher than normal for SSc in first-degree relatives and 10-27-fold higher than Normal for SSc in siblings, and thus represents the strongest susceptibility factor Yet reported for this disease .

Detailed Description

Participates- 400 participates, males and females, 3-80 years old Study Plan

  1. Review of trial method
  2. Signing informed consent
  3. Video-capillaroscopy
  4. Questioning
  5. Conclusions
  6. Only for pathological findings-blood exams and follow-up at rheumatology clinic
  7. Analysis of entire data
  8. Final report Timeliness- After E.C Approvals- 2 years. Confidentiality & Privacy - As common in clinical trials, according to GCP and MOH guidelines.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population first Grade family member to systemic sclerosis patient.
Condition According to the IRB Approval
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 8, 2016)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patient hereby declare that he\she agree to participate the clinical trial, as detailed in the Informed Consent and sign the Informed Consent.
  2. Patient is first Grade family member to systemic sclerosis patient.

Exclusion Criteria:

  1. Patient refuses to sign Informed Consent.
  2. Patient isn't first Grade family member to systemic sclerosis patient.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02795221
Other Study ID Numbers SSC-CAPI2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Principal investigator initiates
Responsible Party yair levy, Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Meir Medical Center
Verification Date June 2016