UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049128 |
|---|---|
| Receipt number | R000055368 |
| Scientific Title | Prospective study for assessing the disease activity of Crohn's disease by using LRG and fecal calprotectin. |
| Date of disclosure of the study information | 2022/10/05 |
| Last modified on | 2024/04/06 09:27:21 |
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Basic information
Public title
Prospective study for assessing the disease activity of Crohn's disease by using LRG and fecal calprotectin.
Acronym
Prospective study for assessing the disease activity of CD by using LRG and FC.
Scientific Title
Prospective study for assessing the disease activity of Crohn's disease by using LRG and fecal calprotectin.
Scientific Title:Acronym
Prospective study for assessing the disease activity of CD by using LRG and FC.
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the usefulness between LRG and fecal calprotectin to assess Crohn's disease activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictive ability of LRG and fecal calprotectin for mucosal healing in Crohn's disease.
Key secondary outcomes
Correlation between LRG or fecal calprotectin and endoscopic activity in Crohn's disease.
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
Patients with inflammatory bowel disease
Key exclusion criteria
Patients under 20 years old
Contraindicated patients for endoscopy
Patients with autoimmune diseases other than inflammatory bowel disease
Patients with malignancy
Patients that the doctor deems inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-741-2111
tyamamu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Kawamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-741-2111
Homepage URL
t-kawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital ethics committee
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-741-2111
ethics@med.nagoya-u.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 | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospectively investigate whether LRG or fecal calprotectin is more predictive of inflammatory bowel disease activity.
Management information
Registered date
| 2022 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055368
