NCT05365009Recruiting
Registry of Autoimmune Interstitial Lung Disease
Characteristics of Patients With Autoimmune Interstitial Lund Disease From Argentina
Source: ClinicalTrials.gov · Last updated 6 May 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Interstitial lung diseases (ILD) constitute a group of entities characterized by inflammation and/or fibrosis of the lung parenchyma. In recent years, with the advent of new diagnostic tools and therapeutic options, multidisciplinary evaluation is essential, since it optimizes the interpretation of each case and the quality of care for these pathologies Consensus for the identification and management of ILD associated with SSc (ILD-SSc) is the only guideline published at present. In the others autoimmune ILD (Ai-ILD), screening, diagnosis, treatment and follow-up strategies are usually performed according to the criteria of the treating medical team. Guidelines regarding the follow-up and indication of immunosuppressive and antifibrotic treatment are lacking. Many questions on the horizon of the Ai-ILD should be answered as better quality evidence emerges from studies with a greater number of patients and better methodological design.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 9 Mar 2022
- Start date
- 10 Apr 2022
- Primary completion date
- Apr 2023
- Lead sponsor
- EPIMAR registry
- NCT number
- NCT05365009
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 10 Apr 2022 to the primary completion date, Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ILD associated with another non-autoimmune etiology according to the criteria of the multidisciplinary team (eg, occupational diseases, toxic)
Other
- Not being able to perform the clinical follow-up or the complementary studies required in the protocol.
- Not being able to be evaluated by a multidisciplinary team; at least a rheumatologist plus a pulmonologist.
Who the study is looking for
- Age ≥ 18 years old
- Diagnosis of ILD within the last 5 years according to the criteria of the multidisciplinary team composed of at least one pulmonologist and one rheumatologist, with or without respiratory symptoms.
- ILD defined by the presence of ground glass opacities and / or peribronchovascular or airspace consolidations and / or reticulations and / or traction bronchiectasis and / or honeycomb on high-resolution computed tomography (HRCT) within the last 12 months 17 .
- One of the following three criteria (see annex 1):
- Established or early stage CTD 18-30. IPAF according to ATS / ERS 2015 classification criteria 8 ANCA positivity by immunofluorescence confirmed by ELISA, with or without systemic vasculitis 31.
- Spirometry performed within the last 6 months before entering the registry.
- The participant must sign the informed consent voluntarily.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Epimar Ii Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.