UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062224 |
|---|---|
| Receipt number | R000071211 |
| Scientific Title | An observational study using proteome analysis in VEGF inhibitor-induced proteinuria |
| Date of disclosure of the study information | 2026/07/13 |
| Last modified on | 2026/07/13 19:06:15 |
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Basic information
Public title
An observational study using proteome analysis in VEGF inhibitor-induced proteinuria
Acronym
An observational study using proteome analysis in VEGF inhibitor-induced proteinuria
Scientific Title
An observational study using proteome analysis in VEGF inhibitor-induced proteinuria
Scientific Title:Acronym
An observational study using proteome analysis in VEGF inhibitor-induced proteinuria
Region
| Japan |
Condition
Condition
Patients with colorectal cancer who are scheduled to initiate VEGF inhibitor therapy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to comprehensively analyze changes in plasma proteins associated with the development of proteinuria in patients treated with vascular endothelial growth factor (VEGF) inhibitors, thereby elucidating the molecular mechanisms involved in the development of proteinuria and identifying potential biomarkers for its early prediction.
Basic objectives2
Others
Basic objectives -Others
Elucidation of pathophysiological mechanisms and biomarker discovery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in plasma protein expression levels between patients with and without VEGF inhibitor-induced proteinuria
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older at the time of enrollment
2) Patients who are able to attend outpatient visits during the study period and are expected to be followed for 6 months
3) Patients who are able to provide written informed consent
Key exclusion criteria
1) Patients with Grade 2 or higher proteinuria before enrollment (urine protein >=2+ and UPCR >=1.0)
2) Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2)
3) Patients with severe hepatic impairment (Child-Pugh class C or an equivalent condition)
4) Patients with an active infection or an unstable general condition
5) Patients who are pregnant, breastfeeding, or may be pregnant
6) Patients who are deemed unsuitable for participation in this study by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenzo |
| Middle name | |
| Last name | Kudo |
Organization
Iwate Medical University
Division name
Division of Clinical Pharmaceutics and Pharmacy Practice, Department of Clinical Pharmacy, School of Pharmacy
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
kenzkudo@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Nihei |
Organization
Iwate Medical University Hospital
Division name
Department of Pharmacy
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
028-613-7111
Homepage URL
satoru@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
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
Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Tel
019-613-7111
satoru@iwate-med.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
Iwate
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 04 | 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
This is a single-center prospective observational study of patients with colorectal cancer initiating VEGF inhibitor therapy. The association between the development of proteinuria after VEGF inhibitor treatment and plasma protein expression profiles will be investigated. Patients will be prospectively followed, and using a nested case-control design, patients with and without proteinuria will be selected at a 1:1 ratio for proteome analysis.
Management information
Registered date
| 2026 | Year | 07 | Month | 13 | Day |
Last modified on
| 2026 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071211
