UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017650 |
|---|---|
| Receipt number | R000020452 |
| Scientific Title | Clinical usefulness of fecal calprotectin for ulcerative colitis |
| Date of disclosure of the study information | 2015/05/22 |
| Last modified on | 2023/02/10 05:08:43 |
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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
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
nagamakoto@z7.keio.ac.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020452
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