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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05998512
Other study ID # PMP/00083
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 10, 2023
Est. completion date December 31, 2025

Study information

Verified date August 2023
Source Institut d'Investigació Biomèdica de Bellvitge
Contact Maria Molina
Phone 932607500
Email ufip@bellvitgehospital.cat
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Other:
Observational register
This is a non-interventional observational registry on patients

Locations

Country Name City State
Spain Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona
Spain Hospital La Princesa Madrid
Spain Hospital Virgen del Rocío Sevilla

Sponsors (1)

Lead Sponsor Collaborator
Institut d'Investigació Biomèdica de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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