UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063033 |
|---|---|
| Receipt number | R000072131 |
| Scientific Title | A prospective study evaluating the effect of CD45-positive cell depletion by magnetic-activated cell sorting on tumor cell content and NGS performance of FFPE cell blocks derived from malignant pleural effusion in patients with non-small cell non-squamous lung cancer |
| Date of disclosure of the study information | 2026/09/24 |
| Last modified on | 2026/09/24 07:10:53 |
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Basic information
Public title
A study of specimen processing methods to enable genomic testing using malignant pleural effusion from patients with lung cancer
Acronym
PLEURA-NGS study
Scientific Title
A prospective study evaluating the effect of CD45-positive cell depletion by magnetic-activated cell sorting on tumor cell content and NGS performance of FFPE cell blocks derived from malignant pleural effusion in patients with non-small cell non-squamous lung cancer
Scientific Title:Acronym
PLEURA-NGS study
Region
| Japan |
Condition
Condition
Malignant pleural effusion from non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate whether CD45-positive cell depletion by magnetic-activated cell sorting (MACS) improves the tumor cell content of FFPE cell blocks derived from malignant pleural effusion in patients with non-squamous non-small cell lung cancer by within-patient comparison with standard processing. The study will also compare DNA/RNA quantity and quality and NGS performance using Oncomine Comprehensive Assay Plus (OCA Plus) between paired specimens to determine whether improved specimen quality translates into improved NGS performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Within-patient comparison of achievement of a tumor cell content of >=20% between FFPE cell blocks prepared by standard processing and MACS processing. Tumor cell content will be assessed pathologically after cell block preparation.
Key secondary outcomes
The following outcomes will be compared within patients between specimens prepared by standard processing and MACS processing:
Tumor cell content as a continuous variable
Tumor cell count
DNA quantity and DNA quality metrics
RNA quantity and RNA quality metrics
Eligibility for GenMineTOP submission
OCA Plus analysis success rate
Major sequencing quality metrics of OCA Plus
Genomic alterations detected by OCA Plus and their variant allele frequencies
Concordance between genomic alterations detected by OCA Plus and previously known driver alterations
Number of patients eligible for GenMineTOP, analysis success, and detected genomic alterations as exploratory outcomes
Pathological and nucleic acid quality assessments will be performed after cell block preparation, and OCA Plus NGS analysis will be performed after DNA/RNA extraction and quality assessment.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with suspected malignant pleural effusion from non-squamous non-small cell lung cancer based on clinical course, imaging, and laboratory findings, or patients already diagnosed with malignant pleural effusion from non-squamous non-small cell lung cancer
2. Patients in whom pleural effusion can be obtained by clinically indicated thoracentesis or chest drainage
3. Both treatment-naive and previously treated patients are eligible, regardless of treatment history
4. Patients aged 18 years or older at the time of informed consent
5. Patients who have received sufficient explanation of the study and provided voluntary written informed consent
For patients without a confirmed diagnosis at enrollment, only those subsequently confirmed by pathological evaluation to have malignant pleural effusion derived from non-squamous non-small cell lung cancer will be included in the final study population.
Key exclusion criteria
1. Patients whose pleural effusion is determined not to be malignant by pathological evaluation after collection
2. Patients in whom malignant cells in the pleural effusion cannot be determined to originate from non-squamous non-small cell lung cancer
3. Patients with insufficient residual pleural effusion to prepare cell blocks using both standard processing and MACS processing
4. Patients considered unsuitable for participation by the principal investigator or study investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Teranishi |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, 241-8515, Japan
TEL
045-520-2222
teranishi.cg60p@kanagawa-pho.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Teranishi |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, 241-8515, Japan
TEL
045-520-2222
Homepage URL
teranishi.cg60p@kanagawa-pho.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kanagawa Prefectural Hospitals Cancer Fund, GenMine Labs
IRB Contact (For public release)
Organization
Kanagawa Cancer Center Research Ethics Committee
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan
Tel
045-520-2222
clinical_trials@kcch.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072131
