UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025390
Receipt number R000029211
Scientific Title Microvilli atrophy in the terminal ileum is a specific endoscopic finding correlated with histological evidence of acute GVHD after allogeneic stem cell transplantation.
Date of disclosure of the study information 2017/01/01
Last modified on 2020/11/06 19:18:42

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Basic information

Public title

Microvilli atrophy in the terminal ileum is a specific endoscopic finding correlated with histological evidence of acute GVHD after allogeneic stem cell transplantation.

Acronym

Microvilli atrophy in the terminal ileum is a endoscopic finding correlated with histological evidence of acute GVHD

Scientific Title

Microvilli atrophy in the terminal ileum is a specific endoscopic finding correlated with histological evidence of acute GVHD after allogeneic stem cell transplantation.

Scientific Title:Acronym

Microvilli atrophy in the terminal ileum is a endoscopic finding correlated with histological evidence of acute GVHD

Region

Japan


Condition

Condition

acute intestinal GVHD

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigated the incident of characteristic findings of microvilli atrophy in terminal ileum and iner-obsever agreement of finding among experienced endoscopists in multiple centers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The sensitivity, specificity, and positive predictive value of the microvilli atrophy for diagnosis of acute intestinal GVHD.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients were performed colonoscopic examinations after allo-SCT in our institute between May 2008 and September 2015.

Key exclusion criteria

Patietns underwent colon surgery
Patients were unable to undergo total colonoscopy because of incomplete preparation or unbearable pain and were not included in the study.

Target sample size

57


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sakiko Hiraoka

Organization

Okayama University Graduate School of Medicine, Okayama, Japan

Division name

Department of Gastroenterology and Hepatology,

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

(+81)-86-235-7219

Email

sakikoh@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuusaku Sugiharaq

Organization

Okayama University Graduate School of Medicine, Okayama, Japan

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

(+81)-86-235-7219

Homepage URL


Email

y.sugi117@gmail.com


Sponsor or person

Institute

Okayama University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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 01 Month 01 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

2016 Year 10 Month 01 Day

Date of IRB

2020 Year 11 Month 06 Day

Anticipated trial start date

2016 Year 10 Month 10 Day

Last follow-up date

2020 Year 11 Month 06 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2016 Year 12 Month 23 Day

Last modified on

2020 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029211


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name