UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000027799