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

NCT05998512 | Unknown DMC

• 1 other identifier: PMP/00083
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• Differences and commonalities in genetic, genomic and environmental exposures/lifestyle in fibrotic ILDs depending on the entity, disease behavior (progressive fibrosis) and treatment response

  Record demographic, epidemiological, clinical, physiological and lung morphology (radiological +/- histological) information. Obtain genetic variation, telomere length, and serum protein markers. Investigate environmental exposures (including air-pollution)

  3 years

• Integration of the biomarkers that most impact on prognosis and treatment response in diagnostic algorithms

  Integrative analytical methods to identify endotypes, predictive biomarkers of disease trajectories, theragnostic biomarkers and new therapeutic targets.

  3 years

• Feasibility and cost of implementing a P4 strategy in clinical practice for fibrotic ILDs

  Development of a predictive score for prognosis and improving the diagnostic approach through biological data to reduce invasive procedures, and estimation educational requirement and potential health cost implications.

  3 years

Interventions

Observational register OTHER

This is a non-interventional observational registry on patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years with diagnosis of fibrotic ILD of any type in the 12 months prior to inclusion, and radiologic fibrotic changes of at least 5% on chest CT scan.

You may qualify if:

• Age \> 18 years
• Signed informed consent
• 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.

You may not qualify if:

• Pregnancy or breastfeeding
• Inability to complete required visits.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead

Study Sites (3)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital La Princesa

Madrid, Spain

RECRUITING

Hospital Virgen del Rocío

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maria Molina

CONTACT

932607500; ufip@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interstitial Lung Diseases Unit

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 21, 2023
• Study Start: July 10, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)