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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024146
Receipt No. 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

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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
Email 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
Email yoshtake@med.showa-u.ac.jp

Sponsor
Institute Showa University, School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027799

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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