UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa
Title of the study (Brief title)	Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa
Region	Japan

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

Objectives
Narrative objectives1	To evaluate histological risk factors for clinical relapse in UC patients with endoscopically mucosal healing.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence or absence of clinical relapse and time to relapse
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	16 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with UC who underwent colonoscopy with biopsies at Kitasato University Kitasato Institute Hospital between April 2012 and May 2016 and endoscopically confirmed Mayo Endoscopic Subscore 0 or 1
Key exclusion criteria	Exacerbations due to infectious gastroenteritis and those complicated with other diseases are excluded from relapses.
Target sample size	150

Research contact person
Name of lead principal investigator	Taku Kobayashi
Organization	Kitasato University Kitasato Institute Hospital
Division name	Center for Advanced IBD Research and Treatment
Address	5-9-1 Shirokane, Minato-ku, Tokyo
TEL	03-3444-6161
Email	kobataku@insti.kitasato-u.ac.jp

Public contact
Name of contact person	Ryo Ozaki
Organization	Kitasato University Kitasato Institute Hospital
Division name	Center for Advanced IBD Research and Treatment
Address	5-9-1 Shirokane, Minato-ku, Tokyo
TEL	03-3444-6161
Homepage URL
Email	deka404@gmail.com

Sponsor
Institute	Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization	Kitasato University Kitasato Institute Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Clinical course until October 2016 was reviewed to assess the association of endoscopic or histological findings and time to clinical relapse. All data were retrospectively collected from the electric medical record (database on the histological diagnosis was prospectively recorded). All endoscopic procedures were performed by the expert gastroenterologists.Biopsies were taken from the rectum or from the colonic mucosa with endoscopically most severe inflammation. All histopathological diagnoses were made by 2 expert pathologists.

Management information
Registered date	2017 Year 11 Month 02 Day
Last modified on	2017 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034027