Systemic Sclerosis (SSc)NCT06579651
Nailfold Capillaroscopic Pattern Changes and Its Correlation with Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) Patients.
An observational study of Systemic Sclerosis (SSc), run by Assiut University.
Trial summary
Detection of different pattern of nail fold capillary changes in SSc patients. Correlation of nail fold capillary changes in SSc patients with ILD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Nailfold videocapillaroscopy (NVC)
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Nov 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cross sectional
Who may be able to join
- Adult SSc Patients
Who cannot join
- 1-SSc patients aged less than 18 years old. 2-Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, connective tissue disease).
- 3-Congestive heart failure and presence of clubbing. 4-history of smoking. 5-Patients unable to co-operate for nail fold capillaroscopic examination.
Trial locations and contacts
No sites are listed yet.
About this study
Detection of different pattern of nail fold capillary changes in SSc patients. Correlation of nail fold capillary changes in SSc patients with ILD.
Read the detailed description
SSc is a connective tissue disease characterized by early microvascular damage and dysfunction and immune system activation, as well as progressive fibrosis in the skin and internal organs.
Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.
Several studies have demonstrated correlations between microvascular damage extent and the severity of internal organ involvement, showing that NVC abnormalities correlate with disease activity and severity and may be also predictive for disease worsening. Furthermore, successful treatments have been shown to reduce NVC abnormalities in SSc cases, and these findings support the importance of NVC in monitoring SSc patients and also suggest its possible role as an outcome measure for microangiopathy in clinical trials.
Three different NVC patterns of microvascular damage have been described (\"early\" , \"active\" , \"late\" ).
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- Nailfold videocapillaroscopy (NVC)
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nailfold videocapillaroscopy (NVC)Device
Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nail fold capillary pattern changes in SSc patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatullah Salaheldin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579651
- Sponsor's protocol ID
- NVC in SSc patients
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nailfold Capillaroscopic Pattern Changes and Its Correlation with Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) Patients.
- ClinicalTrials.gov ID
- NCT06579651
- Acronym / sponsor ID
- NVC in SSc patients
- Conditions
- Systemic Sclerosis (SSc)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- 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.
Detection of different pattern of nail fold capillary changes in SSc patients. Correlation of nail fold capillary changes in SSc patients with ILD.
Detailed description
SSc is a connective tissue disease characterized by early microvascular damage and dysfunction and immune system activation, as well as progressive fibrosis in the skin and internal organs.
Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.
Several studies have demonstrated correlations between microvascular damage extent and the severity of internal organ involvement, showing that NVC abnormalities correlate with disease activity and severity and may be also predictive for disease worsening. Furthermore, successful treatments have been shown to reduce NVC abnormalities in SSc cases, and these findings support the importance of NVC in monitoring SSc patients and also suggest its possible role as an outcome measure for microangiopathy in clinical trials.
Three different NVC patterns of microvascular damage have been described (\"early\" , \"active\" , \"late\" ).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cross sectional
Key inclusion criteria (1 listed)
- Adult SSc Patients
Key exclusion criteria (2 listed)
- 1-SSc patients aged less than 18 years old. 2-Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, connective tissue disease).
- 3-Congestive heart failure and presence of clubbing. 4-history of smoking. 5-Patients unable to co-operate for nail fold capillaroscopic examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nailfold videocapillaroscopy (NVC)Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy. | Device | – |
Primary outcome
Nail fold capillary pattern changes in SSc patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
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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 Systemic Sclerosis (SSc), run by Assiut University.
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 1 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 30 Aug 2024. 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 Mennatullah Salaheldin (+201010616746, mennasalaheldin88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nail fold capillary pattern changes in SSc patients (time frame: baseline). 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 30 Aug 2024.