UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033611
Receipt No. R000038323
Official scientific title of the study Outcomes of transperineal vs transabdominal ultrasound in patients with ulcerative colitis.
Date of disclosure of the study information 2018/08/02
Last modified on 2018/08/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Outcomes of transperineal vs transabdominal ultrasound in patients with ulcerative colitis.
Title of the study (Brief title) Transperineal ultrasound for Ulcerative coltis
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to assess value of perineal ultrasound in patients with ulcerative colitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The intent of the study is to assess disease activity in the patients with ulcerative colitis to calculate the accuracy of transperineal ultrasound compared with transabdominal ultrasound.
Key secondary outcomes 1. Serologic marker
2. Feacal biomarker
3. Endoscopic activity
4. Clinical severity index
5. Evaluation of acceptance
6. Prognosis
7. Histological activity

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients fulfilling all of the following criteria were subjected to the survey.
1. Diagnosed UC patients who underwent colonoscopy according to well-known ciriteria.
2. Patients who understood the purpose of experiment and signed a consent form.
Key exclusion criteria 1. The patient with history of total colectomy.
2. When the principal investigator considered not suitable.
Target sample size 60

Research contact person
Name of lead principal investigator Shintaro Sagami
Organization Kitasato University Kitasato Institute Hospital
Division name Center for Advanced IBD Research and Treatment
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL 03-3444-6161
Email sagami@insti.kitasato-u.ac.jp

Public contact
Name of contact person Shintaro Sagami
Organization Kitasato University Kitasato Institute Hospital
Division name Center for Advanced IBD Research and Treatment
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL 03-3444-6161
Homepage URL
Email sagami@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Kitasato Institute Hospital
Institute
Department

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)

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 08 Month 02 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 08 Month 02 Day
Anticipated trial start date
2018 Year 08 Month 02 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 Recruitment of target people: patients who receive gastrointestinal ultrasound in Kitasato University Kitasato Institute Hospital between 2nd August 2018 and 31th Mar. 2019.

Management information
Registered date
2018 Year 08 Month 02 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038323

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.