Outcome After Treatment of Pulmonary Aspergilloma | NCT01958710

Studies
Outcome After Treatment of Pulmonary Aspergilloma

NCT01958710

Sponsor

University Hospital, Gasthuisberg

Status

Unknown status

Last Update Posted

Oct 9, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Pulmonary Fungal Diseases

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Apr 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Oct 7, 2013

First Submission Date that Met QC Criteria

Oct 7, 2013

First Posted Date

Oct 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2013

Last Update Posted Date

Oct 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johnny Moons, Datamanager Thoracic Surgery, University Hospital, GasthuisbergPrincipal Investigator

Lead Sponsor

University Hospital, GasthuisbergOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Embolisation		(preoperative) embolisation of the bronchial circulation
Surgery		Any surgically treated patient with a functional lung resection (at least wedge resection)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival after treatment	estimated 10 yaer survival after treatment for pulmonary aspergilloma	10 years

Secondary Outcomes

Measure	Description	Time Frame
post treatment survival	survival status at 90 days after initiation of treatment	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological proven Aspergilloma of the lung

Exclusion Criteria:

Treatment limited to the use of systemic antifungal agents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

89 Years

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Herbert Decaluwé, MD	UZ Leuven - dept. Thoracic Surgery	Principal Investigator
Laurence Bertrand, MSc	Katholic University Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Leuven		Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D008172	Lung Diseases, Fungal

Ancestor Terms

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided