UMIN-CTR Clinical Trial

Basic information
Public title	Clinical significance of serum PR3-ANCA in ulcerative colitis
Acronym	Clinical significance of serum PR3-ANCA in ulcerative colitis
Scientific Title	Clinical significance of serum PR3-ANCA in ulcerative colitis
Scientific Title:Acronym	Clinical significance of serum PR3-ANCA in ulcerative colitis
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical significance of serum PR3-ANCA in ulcerative colitis.
Basic objectives2	Others
Basic objectives -Others	Validation of correlation between serum PR3-ANCA and results of clinical examination and/or results of endoscopic activity.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoint is the relationship between ulcerative colitis activity and serum PR3-ANCA.
Key secondary outcomes	To evaluate the background factor and prognosis of serum PR3-ANCA positive in ulcerative colitis.

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	5 years-old <
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Between April 2016 and June 2019, patients with ulcerative colitis that underwent colonoscopy and serum PR3-ANCA measurement within the span of 1 week.
Key exclusion criteria	Cases excluded were patients ages 0 to 5 or with a complication that could be serum positive for PR3-ANCA or MPO-ANCA such as autoimmune disease, chronic extraintestinal inflammatory disease, malignant tumor, or hyperthyroidism, and patients being treated or with a history of treatment with TNF alpha inhibitors, (infliximab and adalimumab), which have the potential to cause drug-induced ANCA-associated vasculitis. Also excluded from analysis were patients being treated or with a history of treatment with steroids or immunoregulators and serum PR3-ANCA levels below the detection limit.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Tomoki Middle name Last name Inaba
Organization	Kagawa Prefectural Central Hospital
Division name	Gastroenterology
Zip code	760-8557
Address	1-2-1, Asahi-cho, Takamatshu city, Kagawa
TEL	087-811-3333
Email	t-inaba@chp-kagawa.jp

Public contact
Name of contact person	1st name YUKI Middle name Last name AOYAMA
Organization	Kagawa Prefectural Central Hospital
Division name	Gastroenterology
Zip code	760-8557
Address	1-2-1, Asahi-cho, Takamatshu city, Kagawa
TEL	087-811-3333
Homepage URL
Email	yublue.med@gmail.com

Sponsor
Institute	Department of Gastroenterology, Kagawa Prefectural Central Hospital
Institute
Department

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	Kagawa Prefectural Central Hospital
Address	1-2-1, Asahi-cho, Takamatshu city, Kagawa
Tel	087-811-3333
Email	yublue.med@gmail.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 01 Month 16 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	158
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 07 Month 01 Day
Date of IRB	2019 Year 07 Month 22 Day
Anticipated trial start date	2019 Year 07 Month 22 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This research is a multi-center, retrospective observational study. The entry will be started after the IRB approval in Kagawa Prefectual Central Hospital and Mitoyo General Hospital.

Management information
Registered date	2020 Year 01 Month 16 Day
Last modified on	2020 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044676