Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.

• ClinicalTrials.gov Identifier: NCT04806412
• Recruitment Status: Unknown
• First Posted: March 19, 2021
• Last Update Posted: May 17, 2022
• Sponsor: Naestved Hospital
• Information provided by (Responsible Party): Naestved Hospital

Tracking Information

• First Submitted Date: March 16, 2021
• First Posted Date: March 19, 2021
• Last Update Posted Date: May 17, 2022
• Actual Study Start Date: March 15, 2021
• Estimated Primary Completion Date: March 12, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2021)

Prevalence of oncodriver status [ Time Frame: assessed at 8 weeks follow-up ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 10, 2022)

• Proportion of adequate and inadequate pleural fluid specimens [ Time Frame: assessed at 8-week follow-up ]
• Amounts of pleural fluid sent for analysis [ Time Frame: assessed at 8-week follow-up ]
  Meassured in mL.
• Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status [ Time Frame: assessed at 8-week follow-up ]
• Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies [ Time Frame: assessed at 8-week follow-up ]
• Prevalence of oncodriver status in additional diagnostic interventions [ Time Frame: assessed at 8-week follow-up ]
• - Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies [ Time Frame: assessed at 8-week follow-up ]
• - Proportion of work-ups where the lack of obtained oncodriver status in pleural fluid specimens leads to additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies [ Time Frame: assessed at 8-week follow-up ]
• - Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis [ Time Frame: assessed at 8-week follow-up ]
• - Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC. [ Time Frame: assessed at 8-week follow-up ]
• Patient assessed pain during thoracentesis [ Time Frame: at day 1, 2 minutes after thoracentesis ]
  assessed by a questionnaire containing a VAS (Visual Analogue Scale, scale 0-10, 0 being no pain, 10 being the worse pain)
• Proportion of patients experiencing pneumothorax [ Time Frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file ]
• Proportion of patients experiencing bleeding [ Time Frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up ]
• Proportion of complications leading to admission [ Time Frame: assessed at 8-week follow-up ]
  assessed by evaluating the patient file

Original Secondary Outcome Measures (submitted: March 16, 2021)

• Proportion of adequate and inadequate pleural fluid specimens [ Time Frame: assessed at 8-week follow-up ]
• Amounts of pleural fluid sent for analysis [ Time Frame: assessed at 8-week follow-up ]
  Meassured in mL.
• Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status [ Time Frame: assessed at 8-week follow-up ]
• Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies [ Time Frame: assessed at 8-week follow-up ]
• Prevalence of oncodriver status in additional diagnostic interventions [ Time Frame: assessed at 8-week follow-up ]
• - Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies [ Time Frame: assessed at 8-week follow-up ]
• - Proportion of work-ups where the lack of obtained oncodriver status in pleural fluid specimens leads to additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies [ Time Frame: assessed at 8-week follow-up ]
• - Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis [ Time Frame: assessed at 8-week follow-up ]
• - Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC. [ Time Frame: assessed at 8-week follow-up ]
• Patient assessed pain after thoracentesis [ Time Frame: at day 1, 10 minutes after thoracentesis ]
  assessed by a questionnaire containing a VAS (Visual Analogue Scale, scale 0-10, 0 being no pain, 10 being the worse pain)
• Proportion of patients experiencing pneumothorax [ Time Frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file ]
• Proportion of patients experiencing bleeding [ Time Frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up ]
• Proportion of complications leading to admission [ Time Frame: assessed at 8-week follow-up ]
  assessed by evaluating the patient file

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
• Official Title: The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

prospective, non-randomized, cohort study

Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition

• Malignant Pleural Effusion
• Non-small Cell Lung Cancer

Intervention

Diagnostic Test: meassurement of PD-L1, ALK, EGFR

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)

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 16, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 12, 2023
• Estimated Primary Completion Date: March 12, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT04806412
• Other Study ID Numbers: SJ-889
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Naestved Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Naestved Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Naestved Hospital
• Verification Date: May 2022