UMIN-CTR Clinical Trial

Basic information
Public title	Clinical usefulness of fecal calprotectin for ulcerative colitis
Acronym	Triple-C study
Scientific Title	Clinical usefulness of fecal calprotectin for ulcerative colitis
Scientific Title:Acronym	Triple-C study
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate relation between fecal calprotectin/fecal occult blood test and endoscopic severity To evaluate usefulness of fecal calprotectin/fecal occult blood test on long-term prognosis of UC
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate relation between fecal calprotectin/fecal occult blood test and endoscopic severity To evaluate usefulness of fecal calprotectin/fecal occult blood test on long-term prognosis of UC
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Patients who were diagnosed as UC 2 Patients who were/will be conducted colonoscopy 3 Informed consent was obtained prior to clinical study 4 Patients whose age are equal to/more than 18 years -old. In addition clinical remission is obtained in case of entry for investigation of clinical outcome
Key exclusion criteria	Patients who received total colectomy Patients who received bowel resection within 6 months prior to entry of this study Patients who have recent GI bleeding, infectious colitis or colonic adenocarcinoma. Patients who received leukocyte or granulocyte- monocyte apheresis therapy. Patients who received non-steroid anti-inflammatory agent (NSAID).
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Takanori Middle name Last name Kanai
Organization	School of Medicine, Keio University
Division name	Division of Gastroenterology and Hepatoligy
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-KU Tokyo
TEL	81-3-3353-1211
Email	takagast@z2.keio.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Naganuma
Organization	School of Medicine, Keio University
Division name	Division of Gastroenterology and Hepatoligy
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-KU Tokyo
TEL	03-3353-1211
Homepage URL
Email	nagamakoto@z7.keio.ac.jp

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	thermoscientific company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio Universisy, School of Medicine
Address	35 Shinanomachi. Shinjuku-ku, Tokyo
Tel	03-333-1211
Email	med-rinri-jimu@adst.keio.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	2015 Year 05 Month 22 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pubmed/31394288
Publication of results	Partially published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/31394288
Number of participants that the trial has enrolled	879
Results	In a nationwide study of patients with UC in Japan, we found that the level of FCP and FIT could each identify patients with endoscopic markers of disease severity.The combination of FCP and FIT results can identify patients in remission who are at risk for disease recurrence.
Results date posted	2019 Year 09 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	To date, most studies on the usefulness of fecal biomarkers have been conducted with relatively small numbers of patients. There have been only a few large multicenter cohort studies on the efficacy of fecal biomarkers for clinical recurrence in patients with UC. Furthermore, it remains unclear whether FCP or FIT levels can reflect the extension of inflammation. Therefore, this nationwide prospective study aims to compare FCP and FIT on the usefulness of assessing endoscopic severity in UC and predicting short- and middle-term prognosis in patients in clinical remission.
Participant flow	A total of 879 patients with UC were enrolled in this study from March 2015 to March 2017. These patients had been recruited from 16 institutions and were randomly enrolled. This study consisted of two cohorts.
Adverse events	None
Outcome measures	The primary endpoint in Cohort 1 was to evaluate the correlation between FCP/FIT and endoscopic severity. The primary endpoint in Cohort 2 was to assess the association between FCP or FIT level at baseline and clinical recurrence for 12 months in patients with UC in clinical remission.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 10 Month 16 Day
Date of IRB	2014 Year 12 Month 12 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2008 Year 12 Month 12 Day
Date analysis concluded	2018 Year 12 Month 15 Day

Other
Other related information	Secondary points are as below To evaluate fecal calprotectin and clinical severity/other biomarkers such as fecal occult blood test or CRP.

Management information
Registered date	2015 Year 05 Month 22 Day
Last modified on	2019 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020452

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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