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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000017650 |
Receipt No. | R000020452 |
Scientific Title | Clinical usefulness of fecal calprotectin for ulcerative colitis |
Date of disclosure of the study information | 2015/05/22 |
Last modified on | 2019/09/08 |
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 |
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Condition | ||
Condition | ulcerative colitis | |
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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). |
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Target sample size | 2000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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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. |
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
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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 |
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Last modified on |
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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 |