UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062331 |
|---|---|
| Receipt number | R000071068 |
| Scientific Title | Prospective multicenter observational study evaluating the diagnostic utility of Rapid On-Site Evaluation of touch-imprint cytology during bronchoscopic biopsy with small forceps for peripheral pulmonary lesions |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/01 17:40:18 |
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Basic information
Public title
Prospective multicenter observational study evaluating the diagnostic utility of Rapid On-Site Evaluation of touch-imprint cytology during bronchoscopic biopsy
with small forceps for peripheral pulmonary lesions
Acronym
ROSE-BARA study
Scientific Title
Prospective multicenter observational study evaluating the diagnostic utility of Rapid On-Site Evaluation of touch-imprint cytology during bronchoscopic biopsy
with small forceps for peripheral pulmonary lesions
Scientific Title:Acronym
Prospective multicenter observational study evaluating the diagnostic utility of Rapid On-Site Evaluation of touch-imprint cytology during bronchoscopic biopsy
with small forceps for peripheral pulmonary lesions
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This observational study aims to determine whether rapid on-site evaluation using touch imprint cytology (ROSE-TIC) of small-forceps biopsy specimens can serve as a diagnostic adjunct for chest abnormalities suspicious for lung cancer. Specifically, in rEBUS-guided bronchoscopy for peripheral pulmonary lesions, we will evaluate the incremental diagnostic yield achieved by adding or modifying sampling procedures in patients with negative ROSE-TIC results and assess its clinical utility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint
Incremental diagnostic yield achieved by procedural modification or additional sampling based on negative ROSE-TIC results.
Key secondary outcomes
Secondary endpoints
Sensitivity, specificity, positive predictive value, negative predictive value, and concordance rate of ROSE-TIC, using the final pathological diagnosis based on bronchoscopic specimens as the reference standard
Safety
Procedure time
Success rate of biomarker testing
Rate of repeat biopsy for diagnostic purposes
Diagnostic yield of histological and cytological examinations
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
Patients with pulmonary lesions suspicious for malignancy on chest radiography and/or chest computed tomography performed within 1 month before bronchoscopy, who are scheduled to undergo bronchoscopic forceps biopsy to determine the treatment strategy.
Patients scheduled to initially undergo either thin bronchoscopy with the EBUS-GS technique or small-forceps biopsy using an ultrathin bronchoscope.
Patients aged 18 years or older.
Patients from whom written informed consent for participation in this study has been obtained.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from this clinical study:
Patients in whom a diagnosis other than lung cancer is strongly suspected.
Patients with lesions located within the inner one-third of the distance from the pulmonary hilum.
Patients scheduled to initially undergo EBUS-TBNA or direct-vision biopsy.
Patients with lesions adjacent to major blood vessels.
Pregnant women or women who may be pregnant.
Patients receiving anticoagulant or antiplatelet therapy that cannot be discontinued for the procedure.
Patients with a marked bleeding tendency.
Patients considered unsuitable for bronchoscopy because of thrombocytopenia (platelet count <50,000/uL) or coagulation abnormalities (prothrombin time or activated partial thromboplastin time) identified on blood testing performed within 1 month before the procedure.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Takigawa |
Organization
NHO Okayama Medical Center
Division name
Department of Respiratory Medicine
Zip code
7011192
Address
1711-1 Okayamashi Kitaku Tamasu
TEL
0862949911
tacky1024@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Takigawa |
Organization
NHO Okayama Medical Center
Division name
IRB
Zip code
7011192
Address
1711-1 Okayamashi Kitaku Tamasu
TEL
0862949911
Homepage URL
tacky1024@gmail.com
Sponsor or person
Institute
NHO Okayama Medical Center
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
Department of Clinical Research, National Hospital Organization Okayama Medical Center, Okayama, Japan
Address
1711-1 Okayamashi Kitaku Tamasu
Tel
0862949911
tacky1024@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 | 08 | Month | 01 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study will investigate whether rapid on-site evaluation using touch imprint cytology (ROSE-TIC) of small-forceps biopsy specimens can serve as a diagnostic adjunct for chest abnormalities suspicious for lung cancer. The study aims to evaluate the incremental diagnostic yield achieved by adding or modifying bronchoscopic sampling procedures in patients with negative ROSE-TIC results during rEBUS-guided bronchoscopy for peripheral pulmonary lesions, and to assess its clinical utility.
Management information
Registered date
| 2026 | Year | 07 | Month | 24 | Day |
Last modified on
| 2026 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071068
