UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056204 |
|---|---|
| Receipt number | R000064222 |
| Scientific Title | Randomized phase 3 trial comparing the utility of adding cryobiopsy versus transbronchial needle aspiration to forceps biopsy during ultrathin bronchoscopy when diagnosing small peripheral pulmonary lesions |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/11/20 00:07:54 |
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Basic information
Public title
Randomized trial assessing the addition cryobiopsy versus transbronchial needle aspiration to ultrathin bronchoscopy for small peripheral pulmonary lesions
Acronym
Cryobiopsy vs. TBNA during ultrathin bronchoscopy (NMC-UT-Cryo 3)
Scientific Title
Randomized phase 3 trial comparing the utility of adding cryobiopsy versus transbronchial needle aspiration to forceps biopsy during ultrathin bronchoscopy when diagnosing small peripheral pulmonary lesions
Scientific Title:Acronym
Cryobiopsy vs. TBNA during ultrathin bronchoscopy to diagnose small peripheral pulmonary lesions (NMC-UT-Cryo 3)
Region
| Japan |
Condition
Condition
Solitary pulmonary lesions
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the histopathological diagnostic yield of combined forceps biopsy and cryobiopsy with combined forceps biopsy and transbronchial needle aspiration using an ultrathin bronchoscope for small peripheral pulmonary lesions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1. Histopathological diagnostic yield
Key secondary outcomes
1. Safety
2. Histopathological diagnostic yield according to disease subtypes
3. Procedure times
4. Histopathological diagnostic yield according to biopsy procedures
5. Overall diagnostic yield
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Forceps biopsy and cryobiopsy using an ultrathin bronchoscope
Interventions/Control_2
Forceps biopsy and TBNA using an ultrathin bronchoscope
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
1. Patients with peripheral pulmonary lesions <= 30 mm in diameter who require a biopsy before deciding on management
2. Age >= 20 years
3. Informed consent given
Key exclusion criteria
1. Any serious, concomitant medical condition
2. Lesion located within the second ellipse from the hilum, as revealed by chest computed tomography
3. Need for a bronchoscopic procedure addressing a non-target lesion in the same setting
4. Lesion near a large vessel
5. Distance < 10 mm between the visceral pleura and central margin of the lesion
6. Prior enrollment in this trial
7. Patients who have undergone or will undergo bronchoscopy between the provision of consent and initiation of the study
8. Pregnancy
9. Inability to temporarily interrupt anticoagulant/antiplatelet agents
10. Bleeding tendency
11. Any other clinical issue identified by a study investigator
Target sample size
540
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Oki |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
masahideo@gmail.com
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Oki |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
Homepage URL
masahideo@gmail.com
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB of National Hospital Organization Nagoya Medical Center
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
Tel
052-951-1111
311-rec@mail.hosp.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 20 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2031 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064222
