Explorative Study on the Molecular Pathology of Lung Fibrosis by Combination of Clinical Assessment and System Biology

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Rolf Ziesche, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01687946
First received: August 23, 2012
Last updated: September 15, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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
Study Population

The participants are chosen from patients lists of participating center.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687946

Contacts
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

Locations
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         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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 July 26, 2014