UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022837 |
|---|---|
| Receipt number | R000026321 |
| Scientific Title | A study to evaluate the safety and efficacy of transbronchial biopsy using the cryoprobe in Japanese |
| Date of disclosure of the study information | 2016/06/23 |
| Last modified on | 2019/08/26 18:03:44 |
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Basic information
Public title
A study to evaluate the safety and efficacy of transbronchial biopsy using the cryoprobe in Japanese
Acronym
CRYO study
Scientific Title
A study to evaluate the safety and efficacy of transbronchial biopsy using the cryoprobe in Japanese
Scientific Title:Acronym
CRYO study
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the safety and efficacy of transbronchial biopsy using the cryoprobe in Japanese.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse events rate
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transbronchial biopsies using the cryoprobe is performed after regular forceps biopsies.
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Suspected lung cancer based on chest CT
2. Age: 20-74 years
3. ECOG performance status 0-2
4. Adequate bone marrow, liver, renal and respiratory function
5. Written informed consent
Key exclusion criteria
1. Patients with serious complication
2. Patients with the possibility of pregnant women, breast-feeding or during pregnancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Goto |
Organization
National Cancer Center Hospital East
Division name
Depertment of Thoracic Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
kgoto@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hibiki Udagawa |
Organization
National Cancer Center Hospital East
Division name
Depertment of Thoracic Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
hudagawa@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Depertment of Thoracic Oncology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 22 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026321
