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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032250
Receipt No. R000036776
Scientific Title Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia
Date of disclosure of the study information 2018/04/14
Last modified on 2018/04/14

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Basic information
Public title Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia
Acronym Dual center study of pCLE for UCAN
Scientific Title Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia
Scientific Title:Acronym Dual center study of pCLE for UCAN
Region
Japan

Condition
Condition suspected ulcerative colitis-associated neoplasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We previously published the usefulness of probe-based confocal laser endomicroscopy (pCLE) for the diangosis of ulcerative colitis-associated neoplasia(UCAN)(Dig Endosc. 2017 Jul;29(5):626-633).Here, we prospectively validate the findings of pCLE for the diagnosis of UCAN in the dual center study (Fujita Health University Hospital and Keio University Hospital).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic yields of pCLE, magnifying narrow band imaging (NBI), and magnifying choromoendoscopy for suspected UCAN, compared with pathological diagnosis.
Key secondary outcomes Adverse events of pCLE and fluorescein

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 pCLE after intravenous administration of fluorescein
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
85 years-old >
Gender Male and Female
Key inclusion criteria Suspected UCAN
Key exclusion criteria 1. Patients with prevous history of allergy to fluorescein
2. Patients in too bad condition to undergo endoscopy.
3. Patients with severe diabetes
4. Patients with severe cardiac disease
5. Patients with severe cerebrovascular disease
6. Patients with cirrhosis
7. Patients with pheochomocytoma
8. Patients with bleeding tendencies
9. Pregnant or possible pregnant women
10. Patients with contraindication of endoscopy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-9240
Email nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9240
Homepage URL
Email nohmiya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Center for Diagnostic and Therapeutic Endoscopy, School of Medicine Keio
University
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 藤田保健衛生大学病院(愛知県)、慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 14 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
Enrolled and validated from now
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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 15 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 05 Month 31 Day
Date analysis concluded
2023 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 14 Day
Last modified on
2018 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036776

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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