UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Real-time diagnosis of Gastrointestinal Graft-Versus-Host-Disease (GI-GVHD) using endoscopic microscopy
Title of the study (Brief title)	Real-time diagnosis of Gastrointestinal Graft-Versus-Host-Disease (GI-GVHD) using endoscopic microscopy
Region	Japan

Condition
Condition	gastrointestinal GVHD(graft-versus-host disease)
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe cellular damage in patients with GI-GVHD using endocytoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the correlations of numbers of goblet cells and crypts with findings in endocytoscopic images and biopsy specimens
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who undergo stem cell transplantation (SCT) in Hokkaido University Hospital are included. 1. the patients who undergo colonoscopy before SCT 2. the patients who are 20 years or older at the agreement acquisition
Key exclusion criteria	The patients who can not receive biopsy for background disease or use of antithrombotic drugs
Target sample size	100

Research contact person
Name of lead principal investigator	Shoko Ono
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Address	Sapporo City, Kita-Ku, North15West7
TEL	+81-11-716-1161
Email	kana.matsuda@true.ocn.ne.jp

Public contact
Name of contact person	Kana Matsuda
Organization	Hokkaido University
Division name	Department of Gastroenterology and Hematology
Address	Sapporo City, Kita-Ku, North15West7
TEL	011-706-5723
Homepage URL
Email	kana.matsuda@true.ocn.ne.jp

Sponsor
Institute	Hokkaido University
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)

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	2018 Year 04 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 30 Day
Anticipated trial start date	2017 Year 07 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	Prospective observational study

Management information
Registered date	2018 Year 04 Month 19 Day
Last modified on	2018 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036613