UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037214 |
|---|---|
| Receipt number | R000042430 |
| Scientific Title | CT guided cryoablation for malignant lung tumor |
| Date of disclosure of the study information | 2019/06/30 |
| Last modified on | 2019/06/30 16:00:20 |
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Basic information
Public title
CT guided cryoablation for malignant lung tumor
Acronym
Cryoablation for malignant lung tumor
Scientific Title
CT guided cryoablation for malignant lung tumor
Scientific Title:Acronym
Cryoablation for malignant lung tumor
Region
| Japan |
Condition
Condition
primary lung cancer, metastatic lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness and complications of cryoablation using liquid nitrogen for primary or metastatic lung cancers are examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
5 years-local control rate
Key secondary outcomes
Complication, 5 years-recurrence-free survival
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
| Maneuver |
Interventions/Control_1
For patients with primary or metastatic lung cancers less than 3 cm, the followings are explained: 1.Standard treatment is surgery if resectable, 2. As non-surgical treatment, the radiation is the first choice, 3. As another non-surgical treatment, the cryoablation is also available. When the patient request the cryoablation, it will be done.
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stage I primary lung cancer less than 3 cm.
Metastatic lung cancer less than 3 cm.
Patients request cryoablation.
Key exclusion criteria
Severe pulmonary dysfunction
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nomori |
Organization
kashiwa kousei General Hospital
Division name
Department of thoracic surgery
Zip code
277-8551
Address
Shikoda 612, Kashiwa city, Chiba
TEL
0471-45-1111
hnomori@qk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nomori |
Organization
kashiwa kousei General Hospital
Division name
Department of thoracic surgery
Zip code
277-8551
Address
Shikoda 612, Kashiwa city, Chiba
TEL
0471-45-1111
Homepage URL
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Department of thoracic surgery, Kashiwa Kousei General Hospital
Institute
Department
Personal name
Funding Source
Organization
kashiwa Kousei General Hospital
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
Kashiwa Kousei General Hospital
Address
Shikoda 617, Kashiwa city, Chiba
Tel
0471-45-1111
hnomori@qk9.so-net.ne.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
| 2019 | Year | 06 | Month | 30 | 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
| 2019 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042430
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
