SarcoidosisMITOSISNCT00888212
Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis
A study testing Bronchoscopy in people with Sarcoidosis, run by University Hospital, Ghent at 15 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the yield of endoscopic guided fine needle aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis stage I-II; but in whom the preceding bronchoscopy did… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jun 2008to Jun 2009
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 y
- Suspicion of thoracic sarcoidosis and need for tissue confirmation
- Recent (<6 weeks) RX and CT-thorax (HRCT not compulsory)
- Fit for bronchoscopy (with or without EBB, TBB, TBNA), esophagoscopy and surgery
- Written informed consent
Who cannot join
- Patients with obvious other organ involvement allowing "simple and safe" biopsy
- Lofgren syndrome
- Pregnancy
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Belgium14 sites
OLV Ziekenhuis Aalst
Aalst
Universitair Ziekenhuis Antwerpen
Antwerp
ZNA Antwerpen
Antwerp
AZ St. Jan Hospitaal Brugge
Bruges
Cliniques Universitaires St. Luc
Brussels
Höpital Erasme Brussel
Brussels
University Hospital Brussels
Brussels
CHU Charleroi
Charleroi
University Hospital Ghent
Ghent, 9000
Virga Jesse Hospitaal
Hasselt
UZ Gasthuisberg Leuven
Leuven
Heilig Hartziekenhuis Menen
Menen
Hôpital Saint Elisabeth Namur
Namur
AZ Oudenaarde
Oudenaarde
About this study
Official title: Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial)
The purpose of this study is to evaluate the yield of endoscopic guided fine needle aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.
- Conditions
- Sarcoidosis
- Being tested
- Bronchoscopy
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopy | Experimental | Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy Receives: Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)
Measured: At the end of study
The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy
Measured: At the end of study
Secondary outcomes (4)
Prevalence of sarcoidosis and alternate diagnosis
Measured: At the end of study
Stage distribution
Measured: At the end of study
Complication rate of each type of procedure
Measured: At the end of study
Cost to obtain a qualifying diagnosis with this strategy in this population
Measured: At the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Kurt G. Tournoy, Md, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888212
- Sponsor's protocol ID
- 2008/069
- Acronym
- MITOSIS
- Status last verified
- Jun 2009
- First submitted
- 24 Apr 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Tournoy KG, Bolly A, Aerts JG, Pierard P, De Pauw R, Leduc D, Leloup A, Pieters T, Slabbynck H, Janssens A, Carron K, Schrevens L, Pat K, De Keukeleire T, Dooms C. The value of endoscopic ultrasound after bronchoscopy to diagnose thoracic sarcoidosis. Eur Respir J. 2010 Jun;35(6):1329-35. doi: 10.1183/09031936.00111509. Epub 2009 Nov 6.
PubMed 19897553
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial)
- ClinicalTrials.gov ID
- NCT00888212
- Acronym / sponsor ID
- MITOSIS / 2008/069
- Conditions
- Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 27 Apr 2009 (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.
The purpose of this study is to evaluate the yield of endoscopic guided fine needle aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy | Experimental | Procedure: BronchoscopyBronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 y
- Suspicion of thoracic sarcoidosis and need for tissue confirmation
- Recent (<6 weeks) RX and CT-thorax (HRCT not compulsory)
- Fit for bronchoscopy (with or without EBB, TBB, TBNA), esophagoscopy and surgery
- Written informed consent
Key exclusion criteria (3 listed)
- Patients with obvious other organ involvement allowing "simple and safe" biopsy
- Lofgren syndrome
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyBronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy | Procedure or surgery | Bronchoscopy |
Primary outcome
The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)
Time frame: At the end of study
The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy
Time frame: At the end of study
4 secondary outcomes
Prevalence of sarcoidosis and alternate diagnosis
Time frame: At the end of study
Stage distribution
Time frame: At the end of study
Complication rate of each type of procedure
Time frame: At the end of study
Cost to obtain a qualifying diagnosis with this strategy in this population
Time frame: At the end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2009.
- Derived from this study: PubMed 19897553Tournoy KG, Bolly A, Aerts JG, Pierard P, De Pauw R, Leduc D, Leloup A, Pieters T, Slabbynck H, Janssens A, Carron K, Schrevens L, Pat K, De Keukeleire T, Dooms C. The value of endoscopic ultrasound after bronchoscopy to diagnose thoracic sarcoidosis. Eur Respir J. 2010 Jun;35(6):1329-35. doi: 10.1183/09031936.00111509. Epub 2009 Nov 6.
- Website of the University Hospital GhentLink provided by the sponsor.
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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.
Kurt G. Tournoy, Md, PhD principal investigator
University Hospital, Ghent
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy in people with Sarcoidosis, run by University Hospital, Ghent at 15 sites in 2 countries.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA) (time frame: At the end of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888212, which also lists 1 linked publication.
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 22 Jun 2009.