UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012159 |
|---|---|
| Receipt number | R000014214 |
| Scientific Title | Immunoreaction after radiofrequency and cryo ablation |
| Date of disclosure of the study information | 2013/10/30 |
| Last modified on | 2019/03/29 15:59:14 |
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Basic information
Public title
Immunoreaction after radiofrequency and cryo ablation
Acronym
Immunoreaction after RF and cryo ablation
Scientific Title
Immunoreaction after radiofrequency and cryo ablation
Scientific Title:Acronym
Immunoreaction after RF and cryo ablation
Region
| Japan |
Condition
Condition
Patients with malignant neoplasms that are treated by RFor cryo ablation
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze immunoreaction in patients who receive RF or cryo ablation.
Basic objectives2
Others
Basic objectives -Others
Immunoreacrion
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Analysis of cytokine
2. Cell-mediated immunity related to tumor antigen
3. Extraction of tumor RNA and DNA
4. Analysis of tumor antigen expression
5. Tumor gene analysis
6. Relashionship between prognosis and analysis results
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Malignant neoplasms
2. Tumor that is treated by RFA or cryoablation
3. 20 years or more.
4. ECOG PS is 0 or 1.
5. Main organs are preserved
1) WBC of 2,500/mm3 or more,
2) Platelet count of 60,000/uL or more,
3) Hb of 10.0g/dL or more,
4) Serum bilirubin of 2.0 mg/dLor less,
5) ASTand ALT of 5 times of the institutionalupper limit or less,
6) Prothrombin time of 50% or less.
6. At least 4 weeks or more from the previous treatment.
7. Informed consent from the patient.
Key exclusion criteria
1) Severe cormorbid disease.
2) Difficulty of oral intake.
3) A physician-in-charge judge as inadequate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Yamakado |
Organization
Mie University Hospital
Division name
Department of Interevntional Radiology
Zip code
Address
2-174 Eddobashi Tsu, Mie
TEL
059-231-5029
yama@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Yamakado |
Organization
Mie University Hospital
Division name
Department of Interevntional Radiology
Zip code
Address
2-174 Eddobashi Tsu, Mie
TEL
059-231-5029
Homepage URL
yama@clin.meic.mie-u.ac.jp
Sponsor or person
Institute
Department of Interevntional Radiology, Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie University 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
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
| 2013 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Immunoreaction and followup results
Management information
Registered date
| 2013 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014214
| Research Plan | |
|---|---|
| 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 |
