UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029800 |
|---|---|
| Receipt number | R000034027 |
| Scientific Title | Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa |
| Date of disclosure of the study information | 2017/11/03 |
| Last modified on | 2017/11/02 06:43:27 |
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Basic information
Public title
Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa
Acronym
Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa
Scientific Title
Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa
Scientific Title:Acronym
Histological Risk Factors to Predict Clinical Relapse in Ulcerative Colitis with Endoscopically Normal Mucosa
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate histological risk factors for clinical relapse in UC patients with endoscopically mucosal healing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of clinical relapse and time to relapse
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with UC who underwent colonoscopy with biopsies at Kitasato University Kitasato Institute Hospital between April 2012 and May 2016 and endoscopically confirmed Mayo Endoscopic Subscore 0 or 1
Key exclusion criteria
Exacerbations due to infectious gastroenteritis and those complicated with other diseases are excluded from relapses.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taku Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
03-3444-6161
kobataku@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Ozaki |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
03-3444-6161
Homepage URL
deka404@gmail.com
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 03 | 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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | 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
Clinical course until October 2016 was reviewed to assess the association of endoscopic or histological findings and time to clinical relapse. All data were retrospectively collected from the electric medical record (database on the histological diagnosis was prospectively recorded). All endoscopic procedures were performed by the expert gastroenterologists.Biopsies were taken from the rectum or from the colonic mucosa with endoscopically most severe inflammation. All histopathological diagnoses were made by 2 expert pathologists.
Management information
Registered date
| 2017 | Year | 11 | Month | 02 | Day |
Last modified on
| 2017 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034027
