UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039174 |
|---|---|
| Receipt number | R000044676 |
| Scientific Title | Clinical significance of serum PR3-ANCA in ulcerative colitis |
| Date of disclosure of the study information | 2020/01/16 |
| Last modified on | 2020/01/16 16:34:12 |
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Basic information
Public title
Clinical significance of serum PR3-ANCA in ulcerative colitis
Acronym
Clinical significance of serum PR3-ANCA in ulcerative colitis
Scientific Title
Clinical significance of serum PR3-ANCA in ulcerative colitis
Scientific Title:Acronym
Clinical significance of serum PR3-ANCA in ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical significance of serum PR3-ANCA in ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
Validation of correlation between serum PR3-ANCA and results of clinical examination and/or results of endoscopic activity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is the relationship between ulcerative colitis activity and serum PR3-ANCA.
Key secondary outcomes
To evaluate the background factor and prognosis of serum PR3-ANCA positive in ulcerative colitis.
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
| 5 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Between April 2016 and June 2019, patients with ulcerative colitis that underwent colonoscopy and serum PR3-ANCA measurement within the span of 1 week.
Key exclusion criteria
Cases excluded were patients ages 0 to 5 or with a complication that could be serum positive for PR3-ANCA or MPO-ANCA such as autoimmune disease, chronic extraintestinal inflammatory disease, malignant tumor, or hyperthyroidism, and patients being treated or with a history of treatment with TNF alpha inhibitors, (infliximab and adalimumab), which have the potential to cause drug-induced ANCA-associated vasculitis. Also excluded from analysis were patients being treated or with a history of treatment with steroids or immunoregulators and serum PR3-ANCA levels below the detection limit.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Inaba |
Organization
Kagawa Prefectural Central Hospital
Division name
Gastroenterology
Zip code
760-8557
Address
1-2-1, Asahi-cho, Takamatshu city, Kagawa
TEL
087-811-3333
t-inaba@chp-kagawa.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | AOYAMA |
Organization
Kagawa Prefectural Central Hospital
Division name
Gastroenterology
Zip code
760-8557
Address
1-2-1, Asahi-cho, Takamatshu city, Kagawa
TEL
087-811-3333
Homepage URL
yublue.med@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Kagawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kagawa Prefectural Central Hospital
Address
1-2-1, Asahi-cho, Takamatshu city, Kagawa
Tel
087-811-3333
yublue.med@gmail.com
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
| 2020 | Year | 01 | Month | 16 | 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
158
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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is a multi-center, retrospective observational study.
The entry will be started after the IRB approval in Kagawa Prefectual Central Hospital and Mitoyo General Hospital.
Management information
Registered date
| 2020 | Year | 01 | Month | 16 | Day |
Last modified on
| 2020 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044676
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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