UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007902 |
|---|---|
| Receipt number | R000009296 |
| Scientific Title | Image evaluation of renal tumor after cryoablation: a prospective study |
| Date of disclosure of the study information | 2012/05/09 |
| Last modified on | 2014/11/07 21:26:07 |
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Basic information
Public title
Image evaluation of renal tumor after cryoablation: a prospective study
Acronym
Image evaluation of renal tumor after cryoablation: a prospective study
Scientific Title
Image evaluation of renal tumor after cryoablation: a prospective study
Scientific Title:Acronym
Image evaluation of renal tumor after cryoablation: a prospective study
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the serial change of CT and MR imaging after cryoablation for the treatment of renal cell carcinoma.
Basic objectives2
Others
Basic objectives -Others
Evaluation for serial change of CT and MR imaging
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of residual enhancement on CT and MR imaging after cryoablation
Key secondary outcomes
Changes in ablative zone size, local tumor progression, survival, and complication
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)Patients with typical RCC diagnosed by histological or clinical examinations.
2)Patients who received cryoablation for the tratment of RCC, and RCC tumor was completely covered by ice-.
3)Patients with hypervascular RCC measuring 7cm or less on contrast-enhanced CT or MR imaging obtained within 2 month before cryoablation.
4)CT or MR imaging evaluations are possible.
5)Patients aged 20 years or over.
6)ECOG performance status of 0-1.
7)Patients who are expected to live more than 3 months.
8)Patients who signed the informed consent to participate in this study.
Key exclusion criteria
1)Patients who are pregnant or suspected to be pregnant.
2)Patients who are concluded to be inappropriate to participate in this study by their physicians.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Yamakado |
Organization
Mie University School of Medicine
Division name
Division of Interventional Radiology
Zip code
Address
Edobashi 2-174, Tsu, Mie
TEL
059-232-1111
takaki-h@clin.medic.me-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruyuki Takaki |
Organization
Mie University School of Medicine
Division name
Division of Interventional Radiology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-232-1111
Homepage URL
takaki-h@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Division of Interventional Radiology
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
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
| 2012 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
In this study, patient who meet the inclusion criteria and not fall under the exclusion criteria are enllolled.
Serial change on contrast-enhancet CT or MR imaging are prospectively evaluated.
Management information
Registered date
| 2012 | Year | 05 | Month | 07 | Day |
Last modified on
| 2014 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009296
