UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042545 |
|---|---|
| Receipt number | R000048563 |
| Scientific Title | Survey on clinical practice regarding cancer chemotherapy and renal disorders using electronic medical record data, and research on related factors and prognosis |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2021/11/30 12:22:04 |
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Basic information
Public title
Anti-VEGF inhibitors and Renal Safety in Onco-Nephrology consortium - Urinary Protein/Creatinine ratio
Acronym
VERSiON UP study
Scientific Title
Survey on clinical practice regarding cancer chemotherapy and renal disorders using electronic medical record data, and research on related factors and prognosis
Scientific Title:Acronym
VERSiON UP study
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Gastroenterology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical usefulness of urinary protein quantitative test (UPCR) as a test for proteinuria, which is an adverse event of angiogenesis inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of less than UPCR 2 in cases with 2+ urinary protein qualitative test
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with gastric or colorectal cancer whose urinary protein qualitative test was 2+ at least once during treatment with angiogenesis inhibitors
Key exclusion criteria
Patients not using angiogenesis inhibitors
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Yanagita |
Organization
Kyoto University Graduate Schpol of medicine
Division name
Nephrology
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3860
motoy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | michio |
| Middle name | |
| Last name | nakamura |
Organization
Sapporo City General Hospital
Division name
Gastroenterology
Zip code
060-8604
Address
1-1, Kita 11 jo Nishi 13 chome, Chuo-ku, Sapporo
TEL
011-726-2211
Homepage URL
michio.nakamura@icloud.com
Sponsor or person
Institute
Onco-Nephrology Consortium
Institute
Department
Personal name
Funding Source
Organization
Sapporo City General Hospital
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
Sapporo City General Hospital
Address
1-1, Kita 11 jo Nishi 13 chome, Chuo-ku, Sapporo
Tel
011-726-2211
michio.nakamura@icloud.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
| 2020 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
71
Results
The proportion of low UPCR in cases whose onset QV status was 2+ (n=53) was 66% (n=35).
In a comparison between low (n=36) and high UPCR cases (n=24), body weight (P=0.036), onset QV status (P=0.013), and worst QV status (P<0.001) were significantly associated with UPCR levels. Body weight was correlated with the worst UPCR value (r=0.392, P=0.002).
Results date posted
| 2021 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From January 2017 to December 2018, 71 patients were enrolled at seven Japanese institutions participating in the Onco-nephrology Consortium. Of the 71 cases with a QV of 2+ or more at least once during the study period, 63 patients had onset QV2+, and eight patients had onset QV3+ or higher.
Participant flow
This was a multi-institutional retrospective observational study conducted at seven institutions in Japan, which participated in the Onco-Nephrology consortium. We investigated all patients with gastric and colorectal cancer patients with a QV of 2+ or more during the use of anti-VEGF/Ri between January 2017 and December 2018. The cutoff date for follow-up was October 30, 2019.
Adverse events
Not applicable
Outcome measures
The primary objective of this study was to investigate the proportion of cases in which the worst UPCR value was less than 2 (low UPCR) in the cases with an onset QV of 2 while using an anti-angiogenesis inhibitor.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 13 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 13 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 16 | Day |
Other
Other related information
From January 1, 2017 to December 31, 2018, 71 cases were registered from 9 participating institutions, of which 53 cases were analyzed as proteinuria 2+.
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048563
