UMIN-CTR Clinical Trial

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
Email	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
Email	michio.nakamura@icloud.com

Sponsor
Institute	Onco-Nephrology Consortium
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048563