Viewing Study NCT04806412



Ignite Creation Date: 2024-05-06 @ 3:54 PM
Last Modification Date: 2024-10-26 @ 2:00 PM
Study NCT ID: NCT04806412
Status: UNKNOWN
Last Update Posted: 2022-05-17
First Post: 2021-03-16

Brief Title: Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer A Prospective Study
Sponsor: Naestved Hospital
Organization: Naestved Hospital

Study Overview

Official Title: The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer A Prospective Study
Status: UNKNOWN
Status Verified Date: 2022-05
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Oncological treatment of patients with disseminated non-small cell lung cancer NSCLC is depending on the status of programmed death-ligand 1 PD-L1 anaplastic lymphoma kinase ALK and epidermal growth factor receptor EGFR so called oncodrivers These can be measured in pleural fluid but the prevalence is uncertain In a prospective study the research team aim to measure PD-L1 ALK and EGFR in patients with pleural fluid cytology positive for NSCLC to report the prevalence Also the study will investigate if the chance of obtaining oncodriver status is depending on the volume analysed and how the lack of oncodrivers influence the following work-up
Detailed Description: The study is a prospective non-randomized cohort study of patients with pleural effusion Participants will be recruited from patients referred to the Pleura Clinic or admitted at the ward at the Department of Respiratory Medicine Næstved Hospital Næstved or at the Department of Respiratory Medicine Zealand University Hospital Roskilde which is the two regional centres for workup of pleural effusions Patients will be referred from either general practice or other hospital departments

Pleural fluids with cytology positive for NSCLC will be tested for oncodrivers for squamous cell carcinomas SCC PD-L1 for adenocarcinomas AC PD-L1 ALK and EGFR

Follow-up will be 8 weeks after inclusion

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None