NCT04618874

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

July 27, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

November 2, 2020

Last Update Submit

July 26, 2022

Conditions

Lung Cancer

Keywords

Lung cancerRapid on-site cytological examinationUltrasound-guided needle aspiration biopsyLung adenocarcinomaMolecular profiling

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield for a tissue diagnosis

    20 days

Secondary Outcomes (3)

  • Diagnostic yield for cancer genotyping

    30 days

  • Diagnostic yield for PDL1 testing

    30 days

  • Complication rate

    7 days

Study Arms (2)

ROSE group

EXPERIMENTAL

Ultrasound-assisted percutaneous needle aspiration with rapid on-site evaluation

Diagnostic Test: Rapid on-site evaluation

US NAB group

NO INTERVENTION

Ultrasound-assisted percutaneous needle aspiration without rapid on-site evaluation

Interventions

Rapid on-site evaluationDIAGNOSTIC_TEST

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

ROSE group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older
  • Provision of a written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Location

Related Publications (3)

  • Meena N, Bartter T. Ultrasound-guided Percutaneous Needle Aspiration by Pulmonologists: A Study of Factors With Impact on Procedural Yield and Complications. J Bronchology Interv Pulmonol. 2015 Jul;22(3):204-8. doi: 10.1097/LBR.0000000000000175.

    PMID: 26165890BACKGROUND

  • Laursen CB, Naur TM, Bodtger U, Colella S, Naqibullah M, Minddal V, Konge L, Davidsen JR, Hansen NC, Graumann O, Clementsen PF. Ultrasound-guided Lung Biopsy in the Hands of Respiratory Physicians: Diagnostic Yield and Complications in 215 Consecutive Patients in 3 Centers. J Bronchology Interv Pulmonol. 2016 Jul;23(3):220-8. doi: 10.1097/LBR.0000000000000297.

    PMID: 27454475BACKGROUND

  • Stigt JA, Oostdijk AH, Boers JE, van den Berg JW, Groen HJ. Percutaneous ultrasound-guided biopsies in the evaluation of thoracic tumours after PET-CT: a prospective diagnostic study. Respiration. 2012;83(1):45-52. doi: 10.1159/000330018. Epub 2011 Sep 16.

    PMID: 21934274BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsAdenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Rocco Trisolini, MD

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 6, 2020

Study Start

March 15, 2021

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

July 27, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)