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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048563


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name