NCT01958710

Brief Summary

Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

6 months

First QC Date

October 7, 2013

Last Update Submit

October 7, 2013

Conditions

Pulmonary Fungal Diseases

Keywords

Catheterization, BronchialPneumonectomyLobectomyThoracoplasty

Outcome Measures

Primary Outcomes (1)

  • survival after treatment

    estimated 10 yaer survival after treatment for pulmonary aspergilloma

    10 years

Secondary Outcomes (1)

  • post treatment survival

    90 days

Study Arms (2)

Embolisation

(preoperative) embolisation of the bronchial circulation

Surgery

Any surgically treated patient with a functional lung resection (at least wedge resection)

Eligibility Criteria

Age1 Year - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Histological proven Aspergilloma of the lung

You may not qualify if:

  • Treatment limited to the use of systemic antifungal agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Lung Diseases, Fungal

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Herbert Decaluwé, MD

    UZ Leuven - dept. Thoracic Surgery

    PRINCIPAL INVESTIGATOR

  • Laurence Bertrand, MSc

    Katholic University Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Datamanager Thoracic Surgery

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

BE(1)