UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060799 |
|---|---|
| Receipt number | R000069561 |
| Scientific Title | Validation of tertiary lymphoid structure (TLS) evaluation using transbronchial cryobiopsy (TBCB) specimens in non-small cell lung cancer: A retrospective study comparing with surgical specimens |
| Date of disclosure of the study information | 2026/03/10 |
| Last modified on | 2026/03/02 16:30:34 |
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Basic information
Public title
Diagnostic validity of tertiary lymphoid structure (TLS) evaluation using transbronchial cryobiopsy (TBCB) specimens in non-small cell lung cancer: A retrospective study comparing with surgical specimens
Acronym
Cryo-TLS study
Scientific Title
Validation of tertiary lymphoid structure (TLS) evaluation using transbronchial cryobiopsy (TBCB) specimens in non-small cell lung cancer: A retrospective study comparing with surgical specimens
Scientific Title:Acronym
Cryo-TLS study
Region
| Japan |
Condition
Condition
Non-small cell carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the concordance of tertiary lymphoid structure (TLS) evaluation (presence and maturity) using transbronchial cryobiopsy (TBCB) specimens with the gold standard surgical specimens in patients with non-small cell lung cancer, and to validate TBCB as a preoperative diagnostic method.
Basic objectives2
Others
Basic objectives -Others
Tertiary lymphoid structures (TLS) in the tumor microenvironment are attracting attention as predictive factors for the efficacy of immune checkpoint inhibitors, but accurate evaluation has been difficult with conventional forceps biopsy due to specimen crushing[cite: 31]. This study uses transbronchial cryobiopsy (TBCB), which allows for larger specimen collection and superior preservation of tissue architecture, to validate the diagnostic validity of TLS evaluation by comparing it with surgical specimens from the same patient. The goal is to establish TBCB as a novel pre-operative biomarker assessment method.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate and Cohen's Kappa coefficient of tertiary lymphoid structure (TLS) evaluation (Positive/Negative) between transbronchial cryobiopsy (TBCB) specimens and surgical specimens
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with non-small cell lung cancer who underwent transbronchial cryobiopsy (TBCB) for preoperative diagnosis at our hospital
Patients who subsequently underwent surgical resection of the primary lesion
Patients whose medical records and preserved pathological specimens (paraffin blocks) are available for analysis
Key exclusion criteria
Cases with insufficient specimen volume for pathological evaluation (presence and maturity of TLS)
Cases that received preoperative chemotherapy or radiotherapy
Other cases deemed inappropriate for this study by the principal investigator
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Sumi |
Organization
Hakodate Goryoukaku Hospital
Division name
Respiratory medicine
Zip code
040-8611
Address
38-3 Goryoukaku-cho Hakodate Hokkaido Japan
TEL
0138-51-2295
tsh715@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Sumi |
Organization
Hakodate Goryoukaku Hospital
Division name
Respiratory medicine
Zip code
040-8611
Address
38-3 Goryoukaku-cho Hakodate Hokkaido Japan
TEL
0138-51-2295
Homepage URL
tsh715@gmail.com
Sponsor or person
Institute
Hakodate Goryoukaku Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakodate Goryoukaku Hospital IRB
Address
38-3 Goryoukaku-cho Hakodate Hokkaido Japan
Tel
0138-51-2295
tsh715@gmail.com
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 | 03 | Month | 10 | 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
22
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069561
