UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052581 |
|---|---|
| Receipt number | R000060002 |
| Scientific Title | A Japan web-based survey on Recurrence after Nephrectomy in Renal Cell Carcinoma Patients |
| Date of disclosure of the study information | 2023/10/27 |
| Last modified on | 2023/10/23 16:10:50 |
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Basic information
Public title
A Japan web-based survey on Recurrence after Nephrectomy in Renal Cell Carcinoma Patients
Acronym
RCC survey
Scientific Title
A Japan web-based survey on Recurrence after Nephrectomy in Renal Cell Carcinoma Patients
Scientific Title:Acronym
RCC survey
Region
| Japan |
Condition
Condition
A Japan web-based survey on Recurrence after Nephrectomy in Renal Cell Carcinoma Patients
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe RCC patientsconcerns on recurrence after surgery. To understand the factors affecting patients preferences for adjuvant therapy.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
none
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The target study population is the group of Japanese RCC patients who underwent nephrectomy enrolled in the Rakuten Panel. Participants who meet the inclusion criteria will be enrolled in this study on a first come basis.
Key exclusion criteria
none
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Takuto |
| Middle name | |
| Last name | Tokudome |
Organization
MSD K.K
Division name
Medical affairs
Zip code
102-8667
Address
1-13-12, Kudan-kita, Chiyoda-ku, Tokyo 1
TEL
03-6272-1000
takuto.tokudome@merck.com
Public contact
Name of contact person
| 1st name | Takuto |
| Middle name | |
| Last name | Tokudome |
Organization
MSD K.K
Division name
Medical affaris
Zip code
102-8667
Address
1-13-12, Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-1000
Homepage URL
ldgproject@merck.com
Sponsor or person
Institute
MSD K.K
Institute
Department
Personal name
Funding Source
Organization
MSD K.K
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
MINS IRB
Address
5-20-9-401 Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2023 | Year | 10 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
na
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060002
