According to the IRB ApprovalSSc NVCNCT02795221
NVC Test in Order to Assess Pathological Changes in Family Members of Patient Diagnosed With SSc
An observational study of According to the IRB Approval, run by Meir Medical Center.
Trial summary
Systemic sclerosis (SSc) is multisystem autoimmune disease of unknown etiology. It's characterized by activation of immune system, microvascular changes and intimal proliferation. Read more about this study
- Who is it for?
- Ages 3 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- According to the IRB Approval
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: first Grade family member to systemic sclerosis patient.
Who may be able to join
- Patient hereby declare that he\she agree to participate the clinical trial, as detailed in the Informed Consent and sign the Informed Consent.
- Patient is first Grade family member to systemic sclerosis patient.
Who cannot join
- Patient refuses to sign Informed Consent.
- Patient isn't first Grade family member to systemic sclerosis patient.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read more
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 .
Read the detailed description
Participates- 400 participates, males and females, 3-80 years old Study Plan
- Review of trial method
- Signing informed consent
- Video-capillaroscopy
- Questioning
- Conclusions
- Only for pathological findings-blood exams and follow-up at rheumatology clinic
- Analysis of entire data
- Final report Timeliness- After E.C Approvals- 2 years. Confidentiality \& Privacy - As common in clinical trials, according to GCP and MOH guidelines.
- Conditions
- According to the IRB Approval
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence of abnormal nailfold capillaroscopy on First Grade Family relatives of patients with Systemic sclerosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for According to the IRB ApprovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yair levy, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795221
- Sponsor's protocol ID
- SSC-CAPI2016
- Acronym
- SSc NVC
- Status last verified
- Jun 2016
- First submitted
- 5 Jun 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Principal investigator initiates
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02795221
- Acronym / sponsor ID
- SSc NVC / SSC-CAPI2016
- Conditions
- According to the IRB Approval
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Review of trial method
- Signing informed consent
- Video-capillaroscopy
- Questioning
- Conclusions
- Only for pathological findings-blood exams and follow-up at rheumatology clinic
- Analysis of entire data
- Final report Timeliness- After E.C Approvals- 2 years. Confidentiality \& Privacy - As common in clinical trials, according to GCP and MOH guidelines.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- first Grade family member to systemic sclerosis patient.
Key inclusion criteria (2 listed)
- Patient hereby declare that he\she agree to participate the clinical trial, as detailed in the Informed Consent and sign the Informed Consent.
- Patient is first Grade family member to systemic sclerosis patient.
Key exclusion criteria (2 listed)
- Patient refuses to sign Informed Consent.
- Patient isn't first Grade family member to systemic sclerosis patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Prevalence of abnormal nailfold capillaroscopy on First Grade Family relatives of patients with Systemic sclerosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Individual participant dataSharing planned: No. Principal investigator initiates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of According to the IRB Approval, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael - Eizikovits, Mrs (972-09-7471936, yael.eizikovits@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Prevalence of abnormal nailfold capillaroscopy on First Grade Family relatives of patients with Systemic sclerosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.