NCT05365009 Registry of Autoimmune Interstitial Lung Disease
| NCT ID | NCT05365009 |
| Status | Recruiting |
| Phase | — |
| Sponsor | EPIMAR registry |
| Condition | Interstitial Lung Disease Due to Systemic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-04-10 |
| Primary Completion | 2023-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-04-10 with a primary completion date of 2023-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * ILD associated with another non-autoimmune etiology according to the criteria of the multidisciplinary team (eg, occupational diseases, toxic)
Contact & Investigator
Florencia Vivero, MD
PRINCIPAL INVESTIGATOR
Sociedad Argentina Reumatologia
Frequently Asked Questions
Who can join the NCT05365009 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Interstitial Lung Disease Due to Systemic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05365009 currently recruiting?
Yes, NCT05365009 is actively recruiting participants. Contact the research team at florenciavivero82@gmail.com for enrollment information.
Where is the NCT05365009 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT05365009 clinical trial?
NCT05365009 is sponsored by EPIMAR registry. The principal investigator is Florencia Vivero, MD at Sociedad Argentina Reumatologia. The trial plans to enroll 1,000 participants.