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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000029629 |
Receipt No. | R000033846 |
Scientific Title | Clinical usefulness of endoscopic assessment in ulcerative colitis using linked color imaging: a preliminary pilot study. |
Date of disclosure of the study information | 2017/10/19 |
Last modified on | 2018/06/06 |
Basic information | ||
Public title | Clinical usefulness of endoscopic assessment in ulcerative colitis using linked color imaging: a preliminary pilot study. | |
Acronym | Evaluation of inflammation of ulcerative colitis using LCI. | |
Scientific Title | Clinical usefulness of endoscopic assessment in ulcerative colitis using linked color imaging: a preliminary pilot study. | |
Scientific Title:Acronym | Evaluation of inflammation of ulcerative colitis using LCI. | |
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 | The aim of this study is to investigate the usefulness of Linked Color Imaging (LCI) to evaluate the activity of mucosal inflammation in ulcerative colitis (UC) patients. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 1.The color differences (delta C) were calculated among WLI and LCI.
2.Correlation between the color differences (delta C) and pathological findings. |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Ulcerative colitis patient
2.Inactive or mildly active UC |
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Key exclusion criteria | 1.Severe or fluminant UC
2.The patients with antithrombotic agents 3.The patients with malignant tumor 4.When the physicians judge that it is inappropriate to be included in this study. |
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Target sample size | 30 |
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Name of lead principal investigator |
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Organization | Takagi hospital
Saga Medical School |
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Division name | Internal Medicine & Gastrointestinal Endoscopy | ||||||
Zip code | |||||||
Address | 141-11 Oazasakemi Okawa Fukuoka, Japan | ||||||
TEL | 0944-87-0001 | ||||||
kymstd@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Saga Medical School | ||||||
Division name | Internal Medicine & Gastrointestinal Endoscopy | ||||||
Zip code | |||||||
Address | 5-1-1 Nabeshima Saga Saga, Japan | ||||||
TEL | 0952-31-6511 | ||||||
Homepage URL | |||||||
kymstd@yahoo.co.jp |
Sponsor | |
Institute | Saga Medical School |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
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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 | 佐賀大学附属病院(佐賀県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Other | |
Other related information | All examinations were conducted with a LASEREO endoscopic system (FUJIFILM CO., Tokyo, Japan). During the colonoscopy, each region of interest (ROI) of terminal ileum, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum was observed by both white light imaging (WLI), and LCI. The Commission international de l'eclairage (CIE) LAB color differences (delta C) were calculated among WLI and LCI in each ROI. After ROI was observed by colonoscopy, the biopsy specimen was taken in each ROI. The correlation between delta C and pathological findings was assessed. |
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=R000033846 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
Registered date | File name |