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OpenTrials
Completed

NCT Number: NCT04618874

US NAB With ROSE Versus US FNAB With no ROSE

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.

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Key information

Conditions

Lung Cancer Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid on-site evaluation

Diagnostic Test

Rapid on site evaluation performed with an MGG quick stain (Bio-Optica, Milano, Italy).

Primary outcomes

  1. Diagnostic yield for a tissue diagnosis

    Time frame: 20 days

Secondary outcomes

  1. Diagnostic yield for cancer genotyping

    Time frame: 30 days

  2. Diagnostic yield for PDL1 testing

    Time frame: 30 days

  3. Complication rate

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

A RANDOMIZED TRIAL COMPARING PERCUTANEOUS ULTRASOUND-GUIDED NEEDLE ASPIRATION/BIOPSY WITH AND WITHOUT RAPID ON SITE EVALUATION IN PATIENTS WITH SUSPECTED SUPERFICIAL METASTASIS FROM LUNG CANCER

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 6, 2020
Registry last updated
Jul 27, 2022

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.

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