UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005790 |
|---|---|
| Receipt number | R000006694 |
| Scientific Title | SURVEILLANCE OF SMALL INTESTINAL ABNORMALITIES IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: A PROSPECTIVE CAPSULE ENDOSCOPY STUDY |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2024/12/25 18:31:05 |
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Basic information
Public title
SURVEILLANCE OF SMALL INTESTINAL ABNORMALITIES IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: A PROSPECTIVE CAPSULE ENDOSCOPY STUDY
Acronym
Investigation of the Lupus Enteritis by Capsule Endoscopy
Scientific Title
SURVEILLANCE OF SMALL INTESTINAL ABNORMALITIES IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: A PROSPECTIVE CAPSULE ENDOSCOPY STUDY
Scientific Title:Acronym
Investigation of the Lupus Enteritis by Capsule Endoscopy
Region
| Japan |
Condition
Condition
systemic lupus erythematosus
Classification by specialty
| Medicine in general | Gastroenterology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine small intestinal lesiosns of SLE by capsule endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
freqency, endoscopic findings
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We perform capsule endoscopy in patients with SLE or suspected SLE from 2011.7.1 to 2013.5.31.
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 SLE, suspected SLE
Key exclusion criteria
NSAIDs user
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-5802-1058
tomoyosi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-5802-1058
Homepage URL
tomoyosi@juntendo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
Juntendo University School of Medicine
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
0338133111
chiken@juntendo.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
| 2011 | Year | 07 | Month | 01 | 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
5
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
Terminated
Date of protocol fixation
| 2011 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 16 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006694
