Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)

NCT ID: NCT05998512

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2025-12-31

Brief Summary

Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)

Background: Interstitial Lung Diseases (ILDs) are a heterogeneous group of >100 different, rare diseases, which share the fate of progressive scarring and, ultimately, death. Two anti-fibrotic drugs have demonstrated to slow-down fibrotic progression and steroids/immunosuppressants are commonly used for inflammatory-driven ILDs. However, patient's response to therapeutic options is variable and unpredictable. Similarly, setting a correct diagnosis is difficult in most cases, especially when patients are too sick for invasive procedures.

Objectives: (1) To investigate the differences and commonalities in genetic, genomic and environmental exposures/lifestyle in fibrotic ILDs depending on the entity, disease behavior (progressive fibrosis) and treatment response; (2) To integrate the biomarkers that most impact on prognosis and treatment response in diagnostic algorithms; and (3) To explore the feasibility and cost of implementing a P4 strategy in clinical practice for fibrotic ILDs.

Methods: The investigators will extend, update and unify existing ILD cohorts (Spanish SEPAR ILD Reg, Observatory IPF.cat, CIBERES IPF and Familial ILD cohorts) in whom the researchers will: (1) record demographic, epidemiological, clinical, physiological and lung morphology (radiological +/- histological) information; (2) obtain genetic variation, telomere length, and serum protein markers; (3) investigate environmental exposures (including air-pollution), (4) apply to integrative analytical methods to identify endotypes, predictive biomarkers of disease trajectories, theragnostic biomarkers and new therapeutic targets. Results (5) will be validated in other fibrotic ILD cohorts (e.g.EuILDRegistry, Mexican fibrotic ILD Registry). Besides, the investigators will explore how to translate this P4 medicine approach in clinical practice; (6) implementing a predictive score for prognosis and improving the diagnostic approach through biological data to reduce invasive procedures, and (7) estimate educational requirement and potential health cost implications.

Viability:This project is viable because: (1) cohorts already exist and can be expanded and updated; (2) investigators have ample expertise in translational research and actively participate in ILD consortia; (3) required knowledge and methodology is already in being used by the consortium.

Clinical relevance: Due to the lethality, high social and economic burden of fibrotic ILDs, identifying the best diagnostic and therapeutic approach through preventive, personalized and precise measures is a unique opportunity to improve survival in these patients and efficiency of health-care resources.

Conditions

Interstitial Lung Disease; Interstitial Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Observational register

This is a non-interventional observational registry on patients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Signed informed consent
• Diagnosis of fibrotic ILD of any type in the 12 months prior to inclusion.
• Radiologic fibrotic changes of at least 5% on chest CT scan
• Ability to comply with the study protocol (in the opinion of the investigator)
• Ability to understand the information given and to sign the informed consent form.

Exclusion Criteria

• Severe, advanced stage or life-limiting chronic diseases prior to the diagnosis of fibrotic ILD, or that represent a high risk of death in the short term (one year after inclusion), such as could be metastatic oncological metastatic diseases, advanced dementia, neurodegenerative diseases in a limiting phase.
• Pregnancy or breastfeeding
• Inability to complete required visits.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Investigació Biomèdica de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Maria Molina

Head of Interstitial Lung Diseases Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Hospital La Princesa

Madrid, , Spain

Site Status: RECRUITING

Hospital Virgen del Rocío

Seville, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maria Molina

Role: CONTACT

ufip@bellvitgehospital.cat

932607500 ext. 8485

Facility Contacts

Jaume Bordas Martinez

Role: primary

ufip@bellvitgehospital.cat

0034 932607689

Claudia Valenzuela, PI

Role: primary

Role: backup

915 20 22 00

Jose Antonio Rodriguez Portal, MD, PhD

Role: primary

Other Identifiers

PMP/00083

Identifier Type: -

Identifier Source: org_study_id