CompletedNot Applicable

US NAB With ROSE Versus US FNAB With no ROSE

Italy136 participantsStarted 2021-03-15

Plain-language summary

This is an investigator-initiated, single center, controlled, randomized clinical trial with two parallel arms in a 1:1 ratio. The objective of the study is to systematically assess the influence of rapid on-site evaluation (ROSE) on the diagnostic yield for diagnosis and molecular profiling, as well as on the safety, of pulmonologist-performed ultrasound-assisted needle aspiration biopsy (US-NAB) of superficial lesions across different metastatic sites in a series of consecutive patients with suspect locally advanced or advanced lung cancer.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Known/suspected lung cancer * Presence of a suspected "superficial" metastasis at imaging studies (CT and/or PET) * Indication to tissue sampling for diagnosis, staging and/or molecular profiling * 18 years or older * Provision of a written informed consent Exclusion Criteria: * Inability or unwillingness to consent * Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP) * Use of antiplatelet (excluded aspirin) or anticoagulant drugs that cannot be discontinued

What they're measuring

Diagnostic yield for a tissue diagnosis

Timeframe: 20 days

Trial details

NCT IDNCT04618874

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-30

View on ClinicalTrials.gov More Lung Cancer trials