UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021402 |
|---|---|
| Receipt number | R000024683 |
| Scientific Title | A study of detection of colitic neoplasia in patients with ulcerative colitis following sensitization with oral 5-aminolevulinic acid using autofluorescence endoscopy |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2016/03/08 23:26:49 |
* 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
Public title
A study of detection of colitic neoplasia in patients with ulcerative colitis following sensitization with oral 5-aminolevulinic acid using autofluorescence endoscopy
Acronym
A study of detection of colitic neoplasia in patients with ulcerative colitis following sensitization with oral 5-aminolevulinic acid using autofluorescence endoscopy
Scientific Title
A study of detection of colitic neoplasia in patients with ulcerative colitis following sensitization with oral 5-aminolevulinic acid using autofluorescence endoscopy
Scientific Title:Acronym
A study of detection of colitic neoplasia in patients with ulcerative colitis following sensitization with oral 5-aminolevulinic acid using autofluorescence endoscopy
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of autofluorescence endoscopy with 5-aminolevulinic acid for colitis associated carcinoma or dysplasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The efficacy of autofluorescence endoscopy with 5-aminolevulinic acid for colitis associated carcinoma or dysplasia
Key secondary outcomes
The estimation of fluorescence signal patterns in colitis associated carcinoma or dysplasia
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
| Device,equipment |
Interventions/Control_1
Autofluorescence endoscopy
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
1)Patients who have diagnosed ulcerative colitis clinically and histopathologically (Duration of disease 8 years or more; pancolitis or left-sided colitis)
2)Lichtiger index<=5
3)Patients who understand the concept of the study and allow to participate in the study with certificate document.
Key exclusion criteria
1)Patients suspected or diagnosed of coagulation disorder or porphyria
2)Patients who are under 18 years old
3)Patients who investigator judged ineligible to register
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kato |
Organization
The Jikei University School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
tkato@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuyoshi Iwasaki |
Organization
The Jikei University School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
tkato@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
東京慈恵会医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 08 | Day |
Last modified on
| 2016 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024683
