UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052117 |
|---|---|
| Receipt number | R000059389 |
| Scientific Title | ablation therapy for small renal cell carcinoma -cryoablation vs radiofrequency ablation- |
| Date of disclosure of the study information | 2023/09/05 |
| Last modified on | 2024/09/05 09:12:45 |
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Basic information
Public title
ablation therapy for small renal cell carcinoma -cryoablation vs radiofrequency ablation-
Acronym
ablation therapy for small renal cell carcinoma -cryoablation vs radiofrequency ablation-
Scientific Title
ablation therapy for small renal cell carcinoma -cryoablation vs radiofrequency ablation-
Scientific Title:Acronym
ablation therapy for small renal cell carcinoma -cryoablation vs radiofrequency ablation-
Region
| Japan |
Condition
Condition
renal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Percutaneous ablation for small renal cell carcinomas includes radiofrequency ablation and cryotherapy, both of which are known to be useful and safe treatments. However, it is still unclear which is the better treatment, which should be used differently, or whether they are still equivalent. This study will provide direction in choosing between radiofrequency ablation and cryotherapy for small renal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CT or MRI scans are performed before and periodically for two years after treatment to determine the effectiveness of treatment. Dynamic examinations using contrast media should be performed whenever possible, unless there are problems such as allergies or renal impairment.
Key secondary outcomes
Pre- and post-operative assessment of renal function, inflammatory response, pain, blood pressure and neurological symptoms, etc at regular intervals
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
cryoablation
Interventions/Control_2
radiofrequency ablation
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
Cases of renal cancer less than 3 cm in length
First treated lesions (however, lesions that have recurred in a different site in the same patient may be included in the study)
Patients undergoing percutaneous ablation treatment for small diameter renal tumors at Kochi Medical School Hospital between after Ethics Committee approval and 2026.3
Key exclusion criteria
Cases which are considered not indication of radiofrequency ablation or cryotherapy at the conference before therapy, etc.
Cases in which the patient's consent cannot be obtained
Cases in which the target lesion has been treated with chemotherapy, molecular targeting, radiotherapy, surgery or other concomitant therapies for one month prior to and during the treatment period (excluding folk therapies that are not based on scientific evidence)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | TAKUJI |
| Middle name | |
| Last name | YAMAGAMI |
Organization
Kochi University, Kochi Medical School
Division name
Department of Diagnostic and Interventional Radiology
Zip code
783-8505
Address
Kohasu, Oko-Cho, Nankoku
TEL
0888802367
yamagami@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKUJI |
| Middle name | |
| Last name | YAMAGAMI |
Organization
Kochi University, Kochi Medical School
Division name
Department of Diagnostic and Interventional Radiology
Zip code
783-8505
Address
Kohasu, Oko-Cho, Nankoku
TEL
0888802367
Homepage URL
yamagami@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University, Kochi Medical School
Institute
Department
Personal name
TAKUJI YAMAGAMI
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
Kochi University, Kochi Medical School
Address
Kohasu, Oko-Cho
Tel
088-880-2180
is21@kochi-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
高知大学医学部附属病院(高知県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059389
