UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051201 |
|---|---|
| Receipt number | R000058393 |
| Scientific Title | The measurement of predictors on acute kidney injury in patients with robot-assisted partial nephrectomy |
| Date of disclosure of the study information | 2023/05/30 |
| Last modified on | 2023/05/30 18:06:23 |
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Basic information
Public title
The measurement of predictors on acute kidney injury in patients with robot-assisted partial nephrectomy
Acronym
The measurement of predictors on acute kidney injury in patients with robot-assisted partial nephrectomy
Scientific Title
The measurement of predictors on acute kidney injury in patients with robot-assisted partial nephrectomy
Scientific Title:Acronym
The measurement of predictors on acute kidney injury in patients with robot-assisted partial nephrectomy
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Nephrology | Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We measure urinary and blood biomarkers in patients with robot-assisted partial nephrectomy to search for indices that predict acute kidney injury.
Basic objectives2
Others
Basic objectives -Others
We measure urinary and blood biomarkers in patients with robot-assisted partial nephrectomy to search for indices that predict acute kidney injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urine and blood biomarker for acute renal injury (L-FABP, NGAL, KIM-1)
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
from August 2019 to March 2020
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Clinically diagnosed as cT1 (including some cT1b) renal cancer by abdominal contrast-enhanced CT (or MRI examination for patients in whom contrast agents are not applicable), and partial nephrectomy is possible
2) No lymph node and metastasis to other intra-abdominal organs (cN0, cM0) by abdominal contrast-enhanced CT (MRI examination for patients who cannot adapt to contrast agents)
3) Chest CT and bone scintigraphy show no metastasis (cM0)
4) Single tumor
5) The latest test values within 6 weeks (42 days) before registration meet all of the criteria for the following items (WBC, Platelet, AST, ALT, T-Bil, Serum creatinine)
6) Aged 20 years or older at the time of informed consent
7) Written consent has been obtained from the patient to participate in the study
Key exclusion criteria
1) Active double cancer
2) History of renal transplantation in the past
3) Receiving treatment for renal cancer within 6 months
4) Inability to discontinue anticoagulants
5) Anemia requiring blood transfusion or bleeding tendency
6) Patients with morbid obesity (BMI 35 over)
7) Patients undergoing dialysis
8) Pregnant women, women who may be pregnant, or women who are breastfeeding
9) Complications of psychiatric disease or psychiatric symptoms and judged to be difficult to participate in the study
10) Other reasons - the principal investigator or subinvestigator of the medical institution participating in this study determines that the participant is ineligible to participate in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Igawa |
Organization
Kurume University School of Medicine
Division name
Department of Urology
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Japan
TEL
0942-31-7572
tigawa@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsunori |
| Middle name | |
| Last name | Matsuo |
Organization
Kurume University School of Medicine
Division name
Department of Urology
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Japan
TEL
0942-31-7572
Homepage URL
mmatsuo@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Urology, Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Kurume University School of Medicine
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
Institutional Review Board, Kurume University Hospital
Address
67 Asahi-machi, Kurume, Japan
Tel
0942-35-3311
i_rinri@kurume-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | 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
23
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
| 2019 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2023 | 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 | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058393
