NCT04806412

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 15, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

March 16, 2021

Last Update Submit

May 10, 2022

Conditions

Malignant Pleural EffusionNon-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Prevalence of oncodriver status

    Prevalence of oncodriver status (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR) in pleural fluid in patients with cytology positive for pulmonary NSCLC

    assessed at 8 weeks follow-up

Secondary Outcomes (13)

  • Proportion of adequate and inadequate pleural fluid specimens

    assessed at 8-week follow-up

  • Amounts of pleural fluid sent for analysis

    assessed at 8-week follow-up

  • Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status

    assessed at 8-week follow-up

  • Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies

    assessed at 8-week follow-up

  • Prevalence of oncodriver status in additional diagnostic interventions

    assessed at 8-week follow-up

  • +8 more secondary outcomes

Interventions

meassurement of PD-L1, ALK, EGFRDIAGNOSTIC_TEST

PD-L1 test will be performed on cell-blocks using PD-L1 antibodies 22C3 and staining platform Dako Omnis (Agilent, Glostrup -Denmark). ALK test will be performed on cell-blocks using staining platform Dako Omnis (Agilent, Glostrup- Denmark) and ALK antibodies "Origene" clone: OT1A4. Sample quality is assessed as for PD-L1. EGFR mutation analysis will be performed as follows: after tumor content evaluation of hematoxylin and eosin stained slides, relevant regions are macrodissected and subjected to a standard genomic DNA extraction procedure using the GeneRead DNA FFPE Kit (Qiagen). Samples will be analysed using the GeneRead QIAact Actionable Insights Tumor Panel (Qiagen)

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Pleural effusion known or suspected of association with NSCLC (pleural fluid cytology positive for cells from NSCLC)
  • Patients must be able to give informed consent

You may not qualify if:

  • Full oncodriver status measured in any pleural fluid in current work-up
  • Inability to understand written or spoken Danish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, 4700, Denmark

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, MalignantCarcinoma, Non-Small-Cell Lung

Interventions

Genes, fms

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsLung Diseases

Intervention Hierarchy (Ancestors)

Proto-OncogenesOncogenesGenes, NeoplasmGenesGenome ComponentsGenomeGenetic StructuresGenetic Phenomena

Central Study Contacts

Katrine Fjaellegaard, MD

CONTACT

31924375kafj@regionsjaelland.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: prospective, non-randomized, cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 19, 2021

Study Start

March 15, 2021

Primary Completion

March 12, 2023

Study Completion

May 12, 2023

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

DK(1)