UMIN-CTR Clinical Trial

Basic information
Public title	The prospective study of the correlation between colonoscopic inflammatory score and biomarkers in patients with ulcerative colitis.
Acronym	UC-LCI-biomarker study
Scientific Title	The prospective study of the correlation between colonoscopic inflammatory score and biomarkers in patients with ulcerative colitis.
Scientific Title:Acronym	UC-LCI-biomarker study
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of blood and fecal biomarkers which correlate with mucosal inflammation in UC
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood and fecal biomarkers which correlate with mucosal inflammation in UC at 12w and 24w
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	UC patients with 1 or more and 10 or less of Mayo score
Key exclusion criteria	1)Patients of severe infectious diseases 2)Patients with severe heart diseases or renal diseases 3)Patients with severe dehydration or increased coagulation ability 4) Patients with malignancy 5) Patients with stoma 6)Patients with colectomy within 12weeks 7)Patients who is not appropriate for this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshikazu Middle name Last name Tsuzuki
Organization	Saitama Medical University
Division name	Department of Gastroenterology
Zip code	3500495
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL	0492761667
Email	ytsuzuki@saitama-med.ac.jp

Public contact
Name of contact person	1st name Yoshikazu Middle name Last name Tsuzuki
Organization	Saitama Medical University
Division name	Department of Gastroenterology
Zip code	3500495
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL	0492761667
Homepage URL
Email	ytsuzuki@saitama-med.ac.jp

Sponsor
Institute	Department of Gastroenterology Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB of Saitama Medical University
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel	0492762143
Email	rinri@saitama-med.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	2022 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	13
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	Completed
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Interim analysis will be performed at the entry of 15 or more patients. This study will be continued until 3 years.

Management information
Registered date	2022 Year 04 Month 01 Day
Last modified on	2022 Year 04 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054016