UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of Patients Reported Outcome of Ulcerative Colitis:prospective multicenter cohort study
Title of the study (Brief title)	PROUC study
Region	Japan

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

Objectives
Narrative objectives1	Development of patients reported outcome of ulcerative colitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Remission after 14 weeks from the start of anti TNF alpha
Key secondary outcomes	Lichtiger score <=4(6 week), Lichtiger score<=2(6,14 week), clinicak effecacy rate(6,14 week),DAI score(14 week), partial DAI score(6,14 week), negative CRP rate(6,14 week),CRP(6,14 week), EQ-5D-3L(1,2,4,8,12 week) QALY, endoscopic remission(12 week)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	moderate and severe UC
Key exclusion criteria	Past history of anti TNF alpha treatment
Target sample size	100

Research contact person
Name of lead principal investigator	Makoto Naganuma
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology Department of Internal Medicine
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL	+81-3-5363-3790
Email	maknaganuma@gmail.com

Public contact
Name of contact person	Masayasu Horibe
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology Department of Internal Medicine
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL	+81-3-5363-3790
Homepage URL
Email	masayasu-horibe@umin.ac.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 05 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 14 Day
Anticipated trial start date	2016 Year 04 Month 19 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	Design:prospective multicenter cohort study. Objective:All consective patients who meet selective citeria in each insntitution. Length: 2016 April to 2018 March Primary outcome:Clinical remission at 14 weeks after treatment Secondary outcome:Lichtiger score, DAI score, partial DAI score, CRP, EQ-5D-3L, QALY, endoscopic remission

Management information
Registered date	2016 Year 05 Month 09 Day
Last modified on	2016 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023712