Pulmonary Fungal DiseasesNCT01958710
Outcome After Treatment of Pulmonary Aspergilloma
An observational study of Pulmonary Fungal Diseases, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma. Read more about this study
- Who is it for?
- Ages 1 year to 89 years
- Conditions the study is for
- Pulmonary Fungal Diseases
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- Histological proven Aspergilloma of the lung
Who cannot join
- Treatment limited to the use of systemic antifungal agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome After Surgical Treatment or Bronchial Embolisation in Aspergilloma of the Lung: a Single Center Experience.
Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.
Read the 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.
- Conditions
- Pulmonary Fungal Diseases
- Keywords
- Catheterization, Bronchial, Pneumonectomy, Lobectomy, Thoracoplasty
- Medical subject headings
- Lung Diseases, Fungal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Embolisation | (preoperative) embolisation of the bronchial circulation | |
| Surgery | Any surgically treated patient with a functional lung resection (at least wedge resection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival after treatment
estimated 10 yaer survival after treatment for pulmonary aspergilloma
Measured: 10 years
Secondary outcomes (1)
post treatment survival
survival status at 90 days after initiation of treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Fungal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Moons, University Hospital, Gasthuisberg
- Investigators
- Herbert Decaluwé, MD, Principal investigator, UZ Leuven - dept. Thoracic SurgeryLaurence Bertrand, MSc, Principal investigator, Katholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958710
- Sponsor's protocol ID
- ASPERLEU
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Surgical Treatment or Bronchial Embolisation in Aspergilloma of the Lung: a Single Center Experience.
- ClinicalTrials.gov ID
- NCT01958710
- Acronym / sponsor ID
- ASPERLEU
- Conditions
- Pulmonary Fungal Diseases
- Keywords
- Catheterization, Bronchial, Pneumonectomy, Lobectomy, Thoracoplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolisation | – | –(preoperative) embolisation of the bronchial circulation |
| Surgery | – | –Any surgically treated patient with a functional lung resection (at least wedge resection) |
Who may qualify
- Ages
- 1 year to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (1 listed)
- Histological proven Aspergilloma of the lung
Key exclusion criteria (1 listed)
- Treatment limited to the use of systemic antifungal agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival after treatment
Time frame: 10 years
estimated 10 yaer survival after treatment for pulmonary aspergilloma
1 secondary outcome
post treatment survival
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
Related trials for Pulmonary Fungal Diseases
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Decaluwé, MD principal investigator
UZ Leuven - dept. Thoracic Surgery
Laurence Bertrand, MSc principal investigator
Katholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fungal Diseases, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival after treatment (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.