UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027464 |
|---|---|
| Receipt number | R000031459 |
| Scientific Title | Study on the relationship between fecal marker (calprotectin, lactoferrin) and magnifying endoscopic stratification in patients with ulcerative colitis in clinical remission |
| Date of disclosure of the study information | 2017/05/23 |
| Last modified on | 2017/05/23 17:22:06 |
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Basic information
Public title
Study on the relationship between fecal marker (calprotectin, lactoferrin) and magnifying endoscopic stratification in patients with ulcerative colitis in clinical remission
Acronym
Study on the relationship between fecal marker (calprotectin, lactoferrin) and magnifying endoscopic stratification in patients with ulcerative colitis in clinical remission
Scientific Title
Study on the relationship between fecal marker (calprotectin, lactoferrin) and magnifying endoscopic stratification in patients with ulcerative colitis in clinical remission
Scientific Title:Acronym
Study on the relationship between fecal marker (calprotectin, lactoferrin) and magnifying endoscopic stratification in patients with ulcerative colitis in clinical remission
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study was to investigate the correlation of fecal calprotectin and lactoferrin levels with MES, UCEIS and ME in patient with UC in clinical remission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Correlations between relapse rate within 1 year and magnifying endoscopic stratification
Key secondary outcomes
1. Correlations between fecal calprotectin, lactoferrin and magnifying endoscopic stratification 2. Correlations between fecal marker concentration and relapse rate within 1 year
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.UC diagnosed by established criteria, age > 20
2.patients in clinical remission, partial UC-disease activity index of <2 and a bloody stool score of 0
3.patient who was acquired informed consent in advance about taking fecal samples, and using their clinical data for this study
Key exclusion criteria
1.active UC
2.liver disease, kidney disease, heart disease, and other severe complications, all of the cases that were judged unsuitable for endoscopy.
3.pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Mine |
Organization
Nagasaki university graduate school of Biomedecal Science
Division name
Department of Gastroenterology and hepatology
Zip code
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki Japan
TEL
0958197481
hyotan999@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichiro Mine |
Organization
Nagasaki university graduate school of Biomedecal Science
Division name
Department of Gastroenterology and hepatology
Zip code
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki Japan
TEL
0958197481
Homepage URL
hyotan999@yahoo.co.
Sponsor or person
Institute
Nagasaki university graduate school of Biomedecal Science
Department of Gastroenterology and hepatology
Institute
Department
Personal name
Funding Source
Organization
Nagasaki university graduate school of Biomedecal Science
Department of Gastroenterology and hepatology
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 | 05 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
patients' background: age, sex, diagnosis
disease information: diagnosis, treatment details
symptoms: Frequency of defecation, degree of bleeding
labratory data: leukocyte counts, erythrocyte counts, Hb, platelet counts, CRP
image findings: endoscopic and magnifying endoscopic findings
Fecal calprotectin, lactoferrin, Hb
Management information
Registered date
| 2017 | Year | 05 | Month | 23 | Day |
Last modified on
| 2017 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031459
