Explorative Study on the Molecular Pathology of Lung Fibrosis by Combination of Clinical Assessment and System Biology
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|ClinicalTrials.gov Identifier: NCT01687946|
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : March 16, 2016
RESOLVE's objective is to identify and characterize validated molecular targets capable of shifting primary organ repair towards fibroproliferative wound healing.
Work package 2 (WP2) of RESOLVE includes the clinical study protocols within the RESOLVE system evaluating different forms of pulmonary repair in humans ranging from normal repair over mainly inflammatory to predominantly fibroproliferative repair.
Fibrosis of the lung is an aberrant and intensified form of wound healing. It is the result of an unresolved disturbance of both initiation and control of repair which is partly age-related. As a result of the relentlessly activated wound healing reaction, mechanisms of inflammation largely representing the condition of chronic inflammation within the peripheral bronchial tree will aggravate this abnormal form of repair.
A systematic comparison of the molecular pathology of fibrotic repair representing
- Varying intensity of fibrosis related to the pathology of usual interstitial pneumonia (UIP),
- Varying inflammatory mechanisms (UIP vs. Hypersensitivity pneumonitis [HP], acute and chronic), and
- Varying stages of age (Normal pulmonary repair in young and old individuals vs. acute/chronic HP vs. UIP) will be able to
- identify molecules capable of shifting regular repair towards fibroproliferative repair and
- elucidate their interrelationship with other molecules forming coordinated yet misdirected metabolic responses characteristic for fibroproliferative repair.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Observational Model:||Case Control|
|Official Title:||Pilot Investigation on the Combined Use of Established Clinical Criteria and Systems Biology for Progressive Pulmonary Fibrosis|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||August 2014|
Pulmonary fibrosis in aged individuals
Group A and B:
Patients with UIP (histologically and/or radiologically proven) providing informed consent. According to functional and radiological assessment, the disease may be either limited (Group A) or advanced (Group B). The patients are usually older than 55 years.
Pulmonary fibrosis and inflammation
Groups C and D:
Patients with HP (histologically and radiologically proven) providing informed consent. According to functional and radiological assessment, the disease will be either acute or chronic. The patients will be significantly younger (mean > 10 years) than in groups A and B.
Regular wound healing in lung
Patients receiving lung biopsy or bronchoscopy for reasons other that the study and volunteers providing informed consent. The group will consist of young (18-40 years) and old individuals (older than 55 years).
- Analysis of lung biopsies by system biology techniques. [ Time Frame: Two measurements within 1 year. ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687946
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Study Chair:||Lutz H Block, MD||Medical University of Vienna|