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Outcome After Treatment of Pulmonary Aspergilloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01958710
Recruitment Status : Unknown
Verified October 2013 by Johnny Moons, University Hospital, Gasthuisberg.
Recruitment status was:  Active, not recruiting
First Posted : October 9, 2013
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):
Johnny Moons, University Hospital, Gasthuisberg

Tracking Information
First Submitted Date October 7, 2013
First Posted Date October 9, 2013
Last Update Posted Date October 9, 2013
Study Start Date October 2013
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2013)
survival after treatment [ Time Frame: 10 years ]
estimated 10 yaer survival after treatment for pulmonary aspergilloma
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 7, 2013)
post treatment survival [ Time Frame: 90 days ]
survival status at 90 days after initiation of treatment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcome After Treatment of Pulmonary Aspergilloma
Official Title Outcome After Surgical Treatment or Bronchial Embolisation in Aspergilloma of the Lung: a Single Center Experience.
Brief Summary Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.
Detailed Description A retrospective chart analysis, based on the search results from a thoracic surgery database and an interventional radiology database. Outcome analysis of all surgically treated patients for a confirmed invasive aspergilloma. Comparisson with (preoperative) embolisation of the bronchial circulation.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

All patients in the database with following interventions will be screened for invasive aspergilloma in the final resection specimen:

Aspergilloma Fungal disease Lung bleeding Destroyed lung Empyema of the lung

Condition Pulmonary Fungal Diseases
Intervention Not Provided
Study Groups/Cohorts
  • Embolisation
    (preoperative) embolisation of the bronchial circulation
  • Surgery
    Any surgically treated patient with a functional lung resection (at least wedge resection)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 7, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Histological proven Aspergilloma of the lung

Exclusion Criteria:

  • Treatment limited to the use of systemic antifungal agents
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 89 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01958710
Other Study ID Numbers ASPERLEU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Johnny Moons, University Hospital, Gasthuisberg
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Gasthuisberg
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Herbert Decaluwé, MD UZ Leuven - dept. Thoracic Surgery
Principal Investigator: Laurence Bertrand, MSc Katholic University Leuven
PRS Account University Hospital, Gasthuisberg
Verification Date October 2013