Lung NeoplasmsNCT02855281

Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer

An observational study of Lung Neoplasms, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a prospective diagnostic pilot study to create hypotheses regarding immunocytochemistry (ICC) PD-L1 analysis of pleural effusions in NSCLC patients as compared to the reference standard of PD-L1 immunohistochemistry (IHC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Neoplasms
How many people: 50 participants
Where: 1 siteGermany
Study dates: Oct 2016to Dec 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The population for selection of potential study participants is comprised of clinical routine patients presenting with (suspected malignant) pleural effusion. These patients must have an indication for pleural puncture. The cause and nature of the pleural effusion at this time point will be unknown in many cases. To establish this, further diagnostic procedures are required. Only patients with confirmed diagnosis of non-small cell lung cancer will be included in the data analysis. A patient in whom suspicion of pleural manifestation of lung cancer is not confirmed, will be considered a screening failure and thus excluded from the study.

Who may be able to join

Presence of malignant pleural effusion with indication for pleural puncture and thoracoscopy
Confirmed diagnosis of non-small cell lung cancer according to ERS guidelines
Written informed consent

Who cannot join

Pregnancy and/or lactation
Acute and life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, etc.)
Any contraindication to undergo thoracoscopy (e.g. anticoagulation therapy which cannot be discontinued for the procedure)
Any medical, psychological or other condition impairing the patient's ability to provide informed consent

Trial locations and contacts

1 site in 1 country.

Germany1 site

Wissenschaftliches Institut Bethanien e. V.
Solingen, North Rhine-Westphalia, 42699

Other trials in Germany

About this study

Conditions: Lung Neoplasms
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02855281
Study group	Role	What they receive
NSCLC with pleural effusion		The population for selection of potential study participants is comprised of clinical routine patients presenting with (suspected malignant) pleural effusion. These patients must have an indication for pleural puncture. The cause and nature of the pleural effusion at this time point will be unknown in many cases. To establish this, further diagnostic procedures are required. Only patients with confirmed diagnosis of non-small cell lung cancer will be included in the data analysis.

What is being measured

The primary outcome is the main question the study is designed to answer.

PD-L1 Prevalence IHC
Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.
Measured: At baseline
PD-L1 Prevalence ICC
Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate
Measured: At baseline
PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis
Based on all cases where PD-L1 analysis was indicated and sucessful (i.e. giving definite results), the immunocytochemistry analysis of PE was compared with the immunohistochemistry analysis of pleural tissue.Two different alternatives were calculated:
- PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive.
- PD-L1 expression with a TPS ≥1% was defined as PD-L1-positive.
Measured: At baseline

Secondary outcomes (2)

PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis
Based on all cases where PD-L1 analysis was indicated, the immunocytochemistry analysis of PE was compared with the immunohistochemistry analysis of pleural tissue.Two different alternatives were calculated:
- PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive.
- PD-L1 expression with a TPS ≥1% was defined as PD-L1-positive. In both instances, cases where PD-L1 analysis could not be performed were defined as negative.
Measured: At baseline
Tumor Cell Detection in Pleural Effusion
Comparing the immunocytochemistry (ICC) analysis of pleural effusion concerning the detection of malignant tumor cells as compared to the immunohistochemistry analysis of pleural tissue. Seven cases of ICC analysis with inconclusive results were defined as negative.
Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Dec 2018

First posted4 Aug 2016 (estimated)
Study startOct 2016
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02855281
Sponsor's protocol ID: WI_16-233
Status last verified: Feb 2021
First submitted: 1 Aug 2016
Last updated: 5 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hagmeyer L, Schafer S, Engels M, Pietzke-Calcagnile A, Treml M, Herkenrath SD, Heldwein M, Hekmat K, Matthes S, Scheel A, Wolf J, Buttner R, Randerath W. High sensitivity of PD-L1 analysis from pleural effusion in nonsmall cell lung cancer. ERJ Open Res. 2021 Mar 22;7(1):00787-2020. doi: 10.1183/23120541.00787-2020. eCollection 2021 Jan.
PubMed 33778051

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT02855281
Acronym / sponsor ID: WI_16-233
Conditions: Lung Neoplasms
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, Heinrich-Heine University, Duesseldorf
Study start: Oct 2016 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 4 Aug 2016 (estimated)
Results: Posted 5 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
NSCLC with pleural effusion	–	–The population for selection of potential study participants is comprised of clinical routine patients presenting with (suspected malignant) pleural effusion. These patients must have an indication for pleural puncture. The cause and nature of the pleural effusion at this time point will be unknown in many cases. To establish this, further diagnostic procedures are required. Only patients with confirmed diagnosis of non-small cell lung cancer will be included in the data analysis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The population for selection of potential study participants is comprised of clinical routine patients presenting with (suspected malignant) pleural effusion. These patients must have an indication for pleural puncture. The cause and nature of the pleural effusion at this time point will be unknown in many cases. To establish this, further diagnostic procedures are required. Only patients with confirmed diagnosis of non-small cell lung cancer will be included in the data analysis. A patient in whom suspicion of pleural manifestation of lung cancer is not confirmed, will be considered a screening failure and thus excluded from the study.

Key inclusion criteria (3 listed)

Presence of malignant pleural effusion with indication for pleural puncture and thoracoscopy
Confirmed diagnosis of non-small cell lung cancer according to ERS guidelines
Written informed consent

Key exclusion criteria (4 listed)

Pregnancy and/or lactation
Acute and life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, etc.)
Any contraindication to undergo thoracoscopy (e.g. anticoagulation therapy which cannot be discontinued for the procedure)
Any medical, psychological or other condition impairing the patient's ability to provide informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

PD-L1 Prevalence IHC
Time frame: At baseline
Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.
PD-L1 Prevalence ICC
Time frame: At baseline
Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate
PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis
Time frame: At baseline
Based on all cases where PD-L1 analysis was indicated and sucessful (i.e. giving definite results), the immunocytochemistry analysis of PE was compared with the immunohistochemistry analysis of pleural tissue.Two different alternatives were calculated: * PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive. * PD-L1 expression with a TPS ≥1% was defined as PD-L1-positive.

2 secondary outcomes

PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis
Time frame: At baseline
Tumor Cell Detection in Pleural Effusion
Time frame: At baseline

Results and safety

Results posted to the registry on 5 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Malignant Pleural Effusion	50	50

Primary outcome: PD-L1 Prevalence IHC

Time frame: At baseline. Count of participants. Unit: Participants

Measure	Number of PD-L1-positive Samples in IHC n = 35
PD-L1 expression with a TPS ≥ 1% was defined as PD-L1-positive: PD-L1 positive	21
PD-L1 expression with a TPS ≥ 1% was defined as PD-L1-positive: PD-L1 negative	14
PD-L1 expression with a TPS ≥ 50% was defined as PD-L1-positive: PD-L1 positive	8
PD-L1 expression with a TPS ≥ 50% was defined as PD-L1-positive: PD-L1 negative	27

Population analysed: Thoracoscopy was performed in all fifty patients. PD-L1 analysis of pleural tissue was indicated in all samples with evidence of tumor cells (n=40), excluding cases with small-cell lung cancer (n=2). Mainly due to insufficient sample material (low tumor cell count) (n=3), PD-L1 analysis could actually be performed in 35 pleural tissue cases.

Primary outcome: PD-L1 Prevalence ICC

Time frame: At baseline. Count of participants. Unit: Participants

Measure	Number of PD-L1-positive Samples in ICC n = 25
PD-L1 expression with a TPS ≥ 1% was defined as PD-L1-positive: PD-L1 positive	19
PD-L1 expression with a TPS ≥ 1% was defined as PD-L1-positive: PD-L1 negative	6
PD-L1 expression with a TPS ≥ 50% was defined as PD-L1-positive: PD-L1 positive	13
PD-L1 expression with a TPS ≥ 50% was defined as PD-L1-positive: PD-L1 negative	12

Population analysed: Pleural puncture was performed in all fifty patients. PD-L1 analysis of pleural effusion was indicated in all samples with evidence of tumor cells (n=36), excluding cases with small-cell lung cancer (n=3). Mainly due to insufficient sample material (low tumor cell count) (n=7) or technical issue (n=1), PD-L1 analysis could actually be performed in 25 pleural effusion cases.

Primary outcome: PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis

Time frame: At baseline. Number (95% Confidence Interval). Unit: percent

Measure	Sensitivity and Specificity of PD-L1 Detection in Pleural Effusion (TPS ≥50%) n = 21	Sensitivity and Specificity of PD-L1 Detection in Pleural Effusion (TPS ≥1%) n = 21
Sensitivity	100 (46 to 100)	86 (56 to 97)
Specificity	63 (36 to 84)	43 (12 to 80)
positive predictive value	45 (18 to 75)	75 (47 to 92)
negative predictive value	100 (66 to 100)	60 (17 to 93)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NSCLC With Pleural Effusion	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): The fact that the PE did not always yield enough material for a comprehensive immunocytochemistry evaluation including PD-L1 analysis, constitutes an important limitation, in part leading to inconclusive results regarding malignancy. This may be due to a low rate of cells scaling off from the pleural lesion and/or a low rate of migration of tumor cells into the pleural fluid.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33778051Hagmeyer L, Schafer S, Engels M, Pietzke-Calcagnile A, Treml M, Herkenrath SD, Heldwein M, Hekmat K, Matthes S, Scheel A, Wolf J, Buttner R, Randerath W. High sensitivity of PD-L1 analysis from pleural effusion in nonsmall cell lung cancer. ERJ Open Res. 2021 Mar 22;7(1):00787-2020. doi: 10.1183/23120541.00787-2020. eCollection 2021 Jan.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Winfried J Randerath, Prof. Dr. principal investigator

Wissenschaftliches Institut Bethanien e.V

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasms, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PD-L1 Prevalence IHC (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02855281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.