UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060388 |
|---|---|
| Receipt number | R000069088 |
| Scientific Title | Prospective Validation Study of the Diagnostic Prediction Model "TIP Score" for Peripheral Transbronchial Needle Aspiration (pTBNA) Using an Ultrathin Bronchoscope (PeriView FLEX) |
| Date of disclosure of the study information | 2026/01/17 |
| Last modified on | 2026/01/17 14:28:01 |
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Basic information
Public title
Observational study to validate the diagnostic prediction score (TIP Score) for peripheral lung lesions using an ultrathin bronchoscope
Acronym
TIP-pTBNA
Scientific Title
Prospective Validation Study of the Diagnostic Prediction Model "TIP Score" for Peripheral Transbronchial Needle Aspiration (pTBNA) Using an Ultrathin Bronchoscope (PeriView FLEX)
Scientific Title:Acronym
TIP-pTBNA Study
Region
| Japan |
Condition
Condition
Peripheral pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively validate the utility and validity of the diagnostic prediction model "TIP Score" for transbronchial needle aspiration (pTBNA) using an ultrathin bronchoscope (PeriView FLEX), which was developed in a retrospective study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological Diagnostic Yield
Key secondary outcomes
Core Acquisition Rate
Safety (Incidence of complications such as pneumothorax and bleeding)
Comparison of Histological Diagnostic Yield between TIP Score groups (High Score group vs. Low Score group)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with peripheral pulmonary lesions confirmed by chest CT or other imaging modalities.
Patients for whom transbronchial needle aspiration (pTBNA) using an ultrathin bronchoscope (PeriView FLEX) is indicated.
Patients who have provided written informed consent to participate in this study.
Patients aged 20 years or older at the time of informed consent.
Key exclusion criteria
Patients for whom bronchoscopy is deemed difficult due to poor general condition or other reasons.
Patients with bleeding tendencies for whom biopsy procedures are contraindicated.
Any other patients deemed inappropriate for participation in this study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Sumi |
Organization
Hakodate Goryoukaku Hospital
Division name
Pulmonary 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 Sumi |
| Middle name | |
| Last name | Sumi |
Organization
Hakodate Goryoukaku Hospital
Division name
Pulmonary 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
Toshiyuki Sumi
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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 | 01 | Month | 17 | 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
Preinitiation
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 | 19 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective study designed to validate the diagnostic prediction model (TIP Score) developed in a preceding retrospective exploratory study.
This study is funded by the departmental budget of the principal investigator. There is no funding from specific industries, and no conflict of interest (COI) to declare.
This study is conducted as an investigator-initiated clinical study (observational study).
Management information
Registered date
| 2026 | Year | 01 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069088
