Sarcoidosis, PulmonarySopranosNCT05759221
Peripheral Airway Biopsy in Sarcoidosis
A study testing Bronchoscopy with airway biopsy in people with Sarcoidosis, Pulmonary, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Airway involvement in sarcoidosis was demonstrated in a meaningful, albeit variable, proportion of patients through biopsy of the central, endoscopically visible airways. Ideally, biopsy of peripheral airways, nowadays possible with the introduction in the market of ultrathin bronchoscopes, might be associated with an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- Bronchoscopy with airway biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2022to 31 Mar 2024
- 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
- Necessity of a pathological confirmation of the clinical and radiological (CT) diagnosis of sarcoidosis.
- Age >18 years
- American Society of Anesthesiologists score 1-3.
Who cannot join
- Inability of unwillingness to consent
- Steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy.
- Pregnancy.
- Uncontrolled coagulopathy
- Contraindication to the temporary interruption of anticoagulants or antiplatelet drugs, except aspirin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Peripheral Airway Biopsy for the Diagnosis of Sarcoidosis
Airway involvement in sarcoidosis was demonstrated in a meaningful, albeit variable, proportion of patients through biopsy of the central, endoscopically visible airways. Ideally, biopsy of peripheral airways, nowadays possible with the introduction in the market of ultrathin bronchoscopes, might be associated with an increased diagnostic yield for the detection of granulomas.
Read the detailed description
Sarcoidosis is a systemic disorder of unknown cause that primarily involves the lung and lymphatic systems and that is more reliably diagnosed if a compatible clinical picture is combined with a pathologic demonstration of non-necrotizing epithelioid-cell granulomas. Endobronchial biopsy (EBB), taken from the central airways with standard-sized videobronchoscopes, has long been used in clinical practice, although its diagnostic yield has been shown to be widely variable across different ethnicities. A recent prospective study shows that the diagnostic yield of EBB in a sarcoidosis population with large prevalence of white Europeans is 37% overall, and 22% in patients who do not have endobronchial abnormalities. The diagnostic yield of biopsies taken from peripheral airways with ultrathin bronchoscopes was never been evaluated, to our knowledge.
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- Bronchoscopy with airway biopsy
- Keywords
- Sarcoidosis, Bronchoscopy
- Medical subject headings
- Sarcoidosis, Pulmonary, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy with airway biopsyProcedure or surgery
Forceps biopsy of peripheral airways under direct endoscopic visualisation.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral airway biopsy arm | Experimental | All patients with clinical and radiological suspicion of sarcoidosis will be submitted to biopsy of peripheral airways (> 6th branching generation). Receives: Procedure: Bronchoscopy with airway biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of peripheral airway biopsy for the detection of granulomas
The diagnostic yield will be calculated on a per patient basis (number of patients in whom the pathological examination of peripheral airway biopsy shows non necrotizing granulomas/all the patients submitted to the sampling procedure).
Measured: 1 month
Secondary outcomes (6)
Complication rate
Incidence of early complications
Measured: 1 day
Diagnostic yield for the detection of endobronchial granulomas according to sex
The association between the sex (male vs female) and the diagnostic yield of peripheral airway biopsy will be assessed
Measured: 6 months
Diagnostic yield for the detection of endobronchial granulomas according to the ethnicity
The association between the ethnicity (white versus other) and the diagnostic yield of peripheral airway biopsy will be assessed
Measured: 6 months
Diagnostic yield for the detection of endobronchial granulomas according to the history of malignancy
The association between a history of malignancy (presence versus absence of any malignancy diagnosed within 5 years of the procedure) and the diagnostic yield of peripheral airway biopsy will be assessed
Measured: 6 months
Diagnostic yield for the detection of endobronchial granulomas according to the sarcoidosis stage
The association between the sarcoidosis stage at CT (I vs II vs II vs IV) and the diagnostic yield of peripheral airway biopsy will be assessed
Measured: 6 months
Diagnostic yield for the detection of endobronchial granulomas according to the presence of large airway mucosal abnormalities
The association between the presence of endoscopically visible large airway abnormalities and the diagnostic yield of peripheral airway biopsy will be assessed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start20 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoidosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocco Trisolini, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759221
- Sponsor's protocol ID
- 5279
- Acronym
- Sopranos
- Status last verified
- Apr 2024
- First submitted
- 6 Feb 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Peripheral Airway Biopsy for the Diagnosis of Sarcoidosis
- ClinicalTrials.gov ID
- NCT05759221
- Acronym / sponsor ID
- Sopranos / 5279
- Conditions
- Sarcoidosis, Pulmonary
- Keywords
- Sarcoidosis, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- 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.
Airway involvement in sarcoidosis was demonstrated in a meaningful, albeit variable, proportion of patients through biopsy of the central, endoscopically visible airways. Ideally, biopsy of peripheral airways, nowadays possible with the introduction in the market of ultrathin bronchoscopes, might be associated with an increased diagnostic yield for the detection of granulomas.
Detailed description
Sarcoidosis is a systemic disorder of unknown cause that primarily involves the lung and lymphatic systems and that is more reliably diagnosed if a compatible clinical picture is combined with a pathologic demonstration of non-necrotizing epithelioid-cell granulomas. Endobronchial biopsy (EBB), taken from the central airways with standard-sized videobronchoscopes, has long been used in clinical practice, although its diagnostic yield has been shown to be widely variable across different ethnicities. A recent prospective study shows that the diagnostic yield of EBB in a sarcoidosis population with large prevalence of white Europeans is 37% overall, and 22% in patients who do not have endobronchial abnormalities. The diagnostic yield of biopsies taken from peripheral airways with ultrathin bronchoscopes was never been evaluated, to our knowledge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral airway biopsy arm | Experimental | Procedure: Bronchoscopy with airway biopsyAll patients with clinical and radiological suspicion of sarcoidosis will be submitted to biopsy of peripheral airways (> 6th branching generation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Necessity of a pathological confirmation of the clinical and radiological (CT) diagnosis of sarcoidosis.
- Age >18 years
- American Society of Anesthesiologists score 1-3.
Key exclusion criteria (5 listed)
- Inability of unwillingness to consent
- Steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy.
- Pregnancy.
- Uncontrolled coagulopathy
- Contraindication to the temporary interruption of anticoagulants or antiplatelet drugs, except aspirin.
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 |
|---|---|---|
| Bronchoscopy with airway biopsyForceps biopsy of peripheral airways under direct endoscopic visualisation. | Procedure or surgery | Peripheral airway biopsy arm |
Primary outcome
Diagnostic yield of peripheral airway biopsy for the detection of granulomas
Time frame: 1 month
The diagnostic yield will be calculated on a per patient basis (number of patients in whom the pathological examination of peripheral airway biopsy shows non necrotizing granulomas/all the patients submitted to the sampling procedure).
6 secondary outcomes
Complication rate
Time frame: 1 day
Diagnostic yield for the detection of endobronchial granulomas according to sex
Time frame: 6 months
Diagnostic yield for the detection of endobronchial granulomas according to the ethnicity
Time frame: 6 months
Diagnostic yield for the detection of endobronchial granulomas according to the history of malignancy
Time frame: 6 months
Diagnostic yield for the detection of endobronchial granulomas according to the sarcoidosis stage
Time frame: 6 months
Diagnostic yield for the detection of endobronchial granulomas according to the presence of large airway mucosal abnormalities
Time frame: 6 months
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 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Rocco Trisolini, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy with airway biopsy in people with Sarcoidosis, Pulmonary, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 5 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 5 Apr 2024. 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 Italy. 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?
Diagnostic yield of peripheral airway biopsy for the detection of granulomas (time frame: 1 month). 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 5 Apr 2024.