According to the IRB Approval Clinical Trial
— SSc NVCOfficial 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
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 .
| Status | Not yet recruiting |
| Enrollment | 400 |
| Est. completion date | June 2017 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 3 Years to 80 Years |
| Eligibility |
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. |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Meir Medical Center |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Prevalence of abnormal nailfold capillaroscopy on First Grade Family relatives of patients with Systemic sclerosis | 1 year | No |