UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029800
Receipt number R000034027
Scientific Title Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa
Date of disclosure of the study information 2017/11/03
Last modified on 2017/11/02 06:43:27

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Basic information

Public title

Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa

Acronym

Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa

Scientific Title

Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa

Scientific Title:Acronym

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

1st name
Middle name
Last name Taku Kobayashi

Organization

Kitasato University Kitasato Institute Hospital

Division name

Center for Advanced IBD Research and Treatment

Zip code


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

1st name
Middle name
Last name Ryo Ozaki

Organization

Kitasato University Kitasato Institute Hospital

Division name

Center for Advanced IBD Research and Treatment

Zip code


Address

5-9-1 Shirokane, Minato-ku, Tokyo

TEL

03-3444-6161

Homepage URL


Email

deka404@gmail.com


Sponsor or person

Institute

Kitasato University Kitasato Institute Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Completed

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034027


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name