Fondazione Policlinico Univeristario A. Gemelli IRCCS
Roma, Italy
NCT Number: NCT05759221
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Roma, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Forceps biopsy of peripheral airways under direct endoscopic visualisation.
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).
Time frame: 1 day
Incidence of early complications
Time frame: 6 months
The association between the sex (male vs female) and the diagnostic yield of peripheral airway biopsy will be assessed
Time frame: 6 months
The association between the ethnicity (white versus other) and the diagnostic yield of peripheral airway biopsy will be assessed
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
The association between the presence of endoscopically visible large airway abnormalities and the diagnostic yield of peripheral airway biopsy will be assessed
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
A Pilot Study of Peripheral Airway Biopsy for the Diagnosis of Sarcoidosis
Acronym: Sopranos
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05374447
Hemic and Lymphatic Diseases, Hypersensitivity
Washington D.C., District of Columbia, United States
View Trial DetailsNCT03727451
Cardiovascular Diseases, Fibrosis
Miami, Florida, United States
View Trial DetailsNCT03793439
Hemic and Lymphatic Diseases, Hypersensitivity
Portland, Oregon, United States
View Trial DetailsNCT03336736
Behavior, Hemic and Lymphatic Diseases
Kingston upon Thames, Surrey, United Kingdom
View Trial Details