UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032250 |
|---|---|
| Receipt number | 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 | 2023/10/08 22:33:46 |
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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
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
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine, Department of Gastroenterology
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
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
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036776
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