UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024146 |
|---|---|
| Receipt number | R000027799 |
| Scientific Title | Can fecal calprotectin be a predictive marker for refractoriness in patients with ulcerative colitis ? |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/03/27 14:05:09 |
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Basic information
Public title
Can fecal calprotectin be a predictive marker for refractoriness in patients with ulcerative colitis ?
Acronym
Fecal calprotectin for refractory ulcerative colitis
Scientific Title
Can fecal calprotectin be a predictive marker for refractoriness in patients with ulcerative colitis ?
Scientific Title:Acronym
Fecal calprotectin for refractory ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate predictive value of fecal calprotectin for refractoriness to medical therapy.
Basic objectives2
Others
Basic objectives -Others
To compare performance of predictive value with those of symptoms and other biomarkers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cut-off value of fecal calprotectin to predict refractoriness and sensitivity, specificity and accuracy based on the cut-off value.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Active ulcerative colitis patients who will recieve 5-aminosalicyrates or corticosteroid for remission induction.
Key exclusion criteria
Patients who are willing to recieve topical therapies, not willing to samlple feces and regular users of non-steroidal antiinflammatory drugs.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Takeuchi |
Organization
Showa University, School of Medicine
Division name
Department of Medicine, Division of Gastroenterology
Zip code
1428666
Address
1-5-8 Hatanodai, Shinagawaku, Tokyo, Japan
TEL
0337848535
yoshtake@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Takeuchi |
Organization
Showa University, School of Medicine
Division name
Department of Medicine, Division of Gastroenterology
Zip code
1428666
Address
1-5-8 Hatanodai, Shinagawaku, Tokyo, Japan
TEL
0337848535
Homepage URL
yoshtake@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University, School of Medicine,
Department of Medicine, Division of Gastroenterology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Showa University, Fujigaoka Hospital
Sapporo Higashi Tokusyukai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University, School of Medicine
Address
1-5-8 Hatanodai, Shinagawaku, Tokyo, Japan
Tel
0337848355
yoshtake@med.showa-u.ac.jp
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
| 2016 | Year | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not specified.
Management information
Registered date
| 2016 | Year | 09 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027799
