Explorative Study on the Molecular Pathology of Lung Fibrosis by Combination of Clinical Assessment and System Biology
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Purpose
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.
Hypothesis
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 |
|---|
|
Pulmonary Fibrosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Pilot Investigation on the Combined Use of Established Clinical Criteria and Systems Biology for Progressive Pulmonary Fibrosis |
- Analysis of lung biopsies by system biology techniques. [ Time Frame: Two measurements within 1 year. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Transbronchial biopsies and Video-assisted throracoscopic biopsies
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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).
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The participants are chosen from patients lists of participating center.
Inclusion criteria:
- Informed consent
- Histological and radiological proof of UIP or HP
Exclusion criteria
- Functionally significant cardiovascular morbidity
- Respiratory insufficiency (PaO2 < 55 mmHg; PaCO2 > 50 mmHg)
- Significant pulmonary hypertension
- Significant pulmonary emphysema
- Non-functional contralateral lung
- Cancer
- Significant coronary heart disease
- Coagulation dysfunction
- Pregnancy, or planning pregnancy during the trial or within three month period thereafter
- Known drug or alcohol abuse within 3 years of screening
- Presumed non-compliance
- Known legal incapacity or limited legal capacity at screening
Contacts and Locations| Contact: Rolf Ziesche, MD | +43-1-40400 ext 6137 | rolf.ziesche@meduniwien.ac.at |
| Contact: David B. Lumenta, MD | 0043-316-385- ext 14685 | david.lumenta@gmail.com |
| Austria | |
| Medical University of Vienna | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Rolf Ziesche, MD +43-1-40400 ext 6137 rolf.ziesche@meduniwien.ac.at | |
| Contact: Eslam Samaha, MD +43-1-40400 ext 4774 eslam.samaha@meduniwien.ac.at | |
| Principal Investigator: Rolf Ziesche, MD | |
| Study Chair: | Lutz H Block, MD | Medical University of Vienna |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rolf Ziesche, Associated Professor of Medicine, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01687946 History of Changes |
| Other Study ID Numbers: | RESOLVE - WP2, HEALTH-F4-2008-202047 |
| Study First Received: | August 23, 2012 |
| Last Updated: | September 15, 2012 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University of Vienna:
|
Biology of Fibrosis |
Additional relevant MeSH terms:
|
Fibrosis Pulmonary Fibrosis Pathologic Processes Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013