UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049329 |
|---|---|
| Receipt number | R000056168 |
| Scientific Title | A randomized controlled trial - efficacy of cryobiopsy in diagnostic bronchoscopy for peripheral pulmonary lesions |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2024/02/19 12:33:42 |
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Basic information
Public title
Efficacy of cryobiopsy for peripheral pulmonary lesions
Acronym
Cryobiopsy RCT
Scientific Title
A randomized controlled trial - efficacy of cryobiopsy in diagnostic bronchoscopy for peripheral pulmonary lesions
Scientific Title:Acronym
Cryobiopsy RCT
Region
| Japan | Asia(except Japan) |
Condition
Condition
Peripheral pulmonary lesion
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the superiority of the diagnostic yield by histology of cryobiopsy over conventional biopsy in patients scheduled for diagnostic bronchoscopy for peripheral pulmonary lesions of 30 mm or smaller. At the same time, we will explore populations in which cryobiopsy is particularly likely to be effective, and compare detailed diagnostic values and safety characteristics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Diagnostic yield by histology
Key secondary outcomes
1) Sensitivity, specificity, and accuracy as to malignancy diagnosis
2) Diagnostic yield by specimen type
3) Cumulative diagnostic yield by number of tissue specimens
4) Incidence of (serious) adverse events
5) Procedure time
6) Success rate of genetic testing
7) Patient reported outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Standard device group (group A)
Biopsies with standard devices (mainly forceps and aspiration needles) are performed.
Interventions/Control_2
Study device group (group B)
Biopsies with the new 1.7-mm or 1.1-mm cryoprobe are performed.
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 who have a PPL that requires diagnosis.
2) Chest thin-section CT (TSCT) is performed within 2 months of enrollment and all the followings are true:
i. The target lesion has a long diameter of 30 mm or smaller as measured by the axial image on the TSCT.
ii. The target lesion is a solitary lesion in the same lobe.
iii. The target lesion is more peripheral than subsegmental bronchi (third generation branches).
3) The target lesion is presumed to be reachable based on the bronchial tree on the TSCT.
4) Age at the time of informed consent is 18 years or older.
5) Participation in the study is agreed in writing by the patient.
Key exclusion criteria
1) Patients who have a past history of any local treatment (e.g., surgery, radiation therapy) for bronchial or pulmonary lesions ipsilateral to the target lesion.
2) Patients who have poorly controlled comorbidities (i.e., severe bronchial asthma, active pulmonary infection, low pulmonary function presenting with chronic respiratory failure, unstable angina, post-acute myocardial infarction, heart failure, and severe bleeding tendency).
3) Patients who have psychosis, psychiatric symptoms, or dementia that interfere with daily life.
4) Patients who take anticoagulant and/or antiplatelet medications and cannot discontinue them for the procedure. However, as for antiplatelet agents, only acetylsalicylic acid may be continued.
5) Other patients who are judged by the attending physician to be inappropriate as the subjects.
Target sample size
660
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiratory Endoscopy Division/Department of Thoracic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
yumatsum@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiratory Endoscopy Division/Department of Thoracic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
yumatsum@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.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
国立がん研究センター中央病院（東京都）
大阪公立大学大学院医学研究科（大阪府）
京都第一赤十字病院（京都府）
和泉市立総合医療センター（大阪府）
上尾中央総合病院（埼玉県）
Sarawak General Hospital（マレーシア）
National Taiwan University Cancer Center（台湾）
Chungnam National University（韓国）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056168
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