UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047038 |
|---|---|
| Receipt number | R000053664 |
| Scientific Title | Investigation of the simple and appropriate method to evaluate renal function in patients with cancer undergoing cisplatin-based chemotherapy |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2025/03/02 11:47:15 |
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Basic information
Public title
Investigation of the simple and appropriate method to evaluate renal function in patients with cancer undergoing cisplatin-based chemotherapy
Acronym
Investigation of the simple and appropriate method to evaluate renal function in patients with cancer undergoing cisplatin-based chemotherapy
Scientific Title
Investigation of the simple and appropriate method to evaluate renal function in patients with cancer undergoing cisplatin-based chemotherapy
Scientific Title:Acronym
Investigation of the simple and appropriate method to evaluate renal function in patients with cancer undergoing cisplatin-based chemotherapy
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the simple and appropriate method to evaluate renal function in patients with cancer undergoing cisplatin-based chemotherapy
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of the simple and appropriate method to evaluate renal function
Key secondary outcomes
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
| Other |
Interventions/Control_1
Measurement of cisplatin concentrations in blood and urine
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
Patients with histologically diagnosed cancer who are planned to receive cisplatin
Key exclusion criteria
Patients undergoing hemodialysis or peritoneal dialysis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eiko |
| Middle name | |
| Last name | Hasegawa |
Organization
Toranomon Hospital
Division name
Nephrology Center
Zip code
105-8470
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
akinari-s@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Akinari |
| Middle name | |
| Last name | Sekine |
Organization
Toranomon Hospital
Division name
Nephrology Center
Zip code
105-8470
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
akinari-s@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
KKR Toranomon Hospital Certified Review Board
Address
2-2-2, Toranomon, Minato-ku, Tokyo
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2022 | Year | 02 | Month | 28 | 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
| 2022 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053664
