UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054125 |
|---|---|
| Receipt number | R000061805 |
| Scientific Title | Investigation of the significance of combining cone-beam CT-guided ultrathin bronchoscopic forceps biopsy with needle biopsy for peripheral pulmonary lesions. |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2024/04/11 21:01:26 |
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Basic information
Public title
Investigation of the significance of combining cone-beam CT-guided ultrathin bronchoscopic forceps biopsy with needle biopsy for peripheral pulmonary lesions.
Acronym
Cone-beam CT-guided ultrafine bronchoscopic needle biopsy.
Scientific Title
Investigation of the significance of combining cone-beam CT-guided ultrathin bronchoscopic forceps biopsy with needle biopsy for peripheral pulmonary lesions.
Scientific Title:Acronym
Cone-beam CT-guided ultrathin bronchoscopic needle biopsy.
Region
| Japan |
Condition
Condition
pulmonary nodular lesion
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the improved diagnostic yield of using cone-beam CT-guided ultra thin bronchoscopy and ultrasound in combination, plus needle biopsy in addition to forceps biopsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare diagnostic yields with forceps biopsy with those with subsequent needle biopsy and forceps biopsy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Forceps biopsy followed by needle biopsy and forceps biopsy
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
1) 18 years of age or older.
2) Patients who are able to obtain their own consent.
3) Patients with a mass or nodule of 30 mm or less in length in the lung field on thin-section CT, suspected lung cancer and requiring bronchoscopy for its diagnosis.
Key exclusion criteria
1) Patients with serious complications
2) Patients with bleeding tendency.
3) Patients allergic to local anaesthetics or sedatives.
4) Pregnant women.
5) Other patients who are expected to have difficulty in performing the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Noaya |
| Middle name | |
| Last name | Kawakita |
Organization
Institute of Biomedical Sciences, The University of Tokushima Graduate School
Division name
Department of Thoracic and Endocrine Surgery and Oncology
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima , Japan
TEL
0886337143
kawakita.naoya@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Kawakita |
Organization
Institute of Biomedical Sciences, The University of Tokushima Graduate School
Division name
Department of Thoracic and Endocrine Surgery and Oncology
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima , Japan
TEL
0886337143
Homepage URL
kawakita.naoya@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School
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
The Ethics Committee of Tokushima University Hospital
Address
3-18-15, Kuramoto-cho, Tokushima , Japan
Tel
088-633-851
first-ec@tokushima-u.ac.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 | 04 | Month | 12 | 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
| 2024 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061805
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| Registered date | File name |
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| Registered date | File name |
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