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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022805
Receipt No. R000025259
Official scientific title of the study Terminal ileum imaging with colonoscopy is marker for evaluation of acute graft-versus-host disease severity after allogeneic bone marrow transplantation.
Date of disclosure of the study information 2016/07/01
Last modified on 2016/06/20

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Basic information
Official scientific title of the study Terminal ileum imaging with colonoscopy is marker for evaluation of acute graft-versus-host disease severity after allogeneic bone marrow transplantation.
Title of the study (Brief title) The colonoscopy is marker for evaluation of acute graft-versus-host disease severity after allogeneic bone marrow transplantation.
Region
Japan

Condition
Condition Intestinal GVHD
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to clarify the clinical significance of endoscopic diagnosis in patients with intestinal GVHD and to investigate this endoscopic diagnosis whether severity of image of colonoscopy with clinical appearance, response to treatment, and mortality attributable to intestinal GVHD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Demographic information
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Patients underwent colonoscopy and had symptoms suggestive of gastrointestinal GVHD
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
0 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria This retrospective study comprised 261 consecutive patients, underwent BMT, referred to the Okayama University Graduate School of Medicine between May 2008 and September 2015.
Key exclusion criteria Participants gave not informed consent.
Target sample size 271

Research contact person
Name of lead principal investigator Sakiko Hiraoka
Organization Okayama University Graduate School of Medicine, Okayama, Japan
Division name Department of Gastroenterology and Hepatology,
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7219
Email sakikoh@cc.okayama-u.ac.jp

Public contact
Name of contact person Yuusaku Sugihara
Organization Okayama University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7219
Homepage URL
Email y.sugi117@gmail.com

Sponsor
Institute Okayama University Graduate School of Medicine
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine
Organization
Division
Category of Funding Organization Government offices of other countries
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 07 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 01 Month 06 Day
Anticipated trial start date
2018 Year 01 Month 07 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

Management information
Registered date
2016 Year 06 Month 20 Day
Last modified on
2016 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025259

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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