UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002868 |
|---|---|
| Receipt number | R000003498 |
| Scientific Title | Evaluation of gastrointestinal oppotunistic infections in patients using steroids |
| Date of disclosure of the study information | 2009/12/10 |
| Last modified on | 2021/12/22 01:17:03 |
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Basic information
Public title
Evaluation of gastrointestinal oppotunistic infections in patients using steroids
Acronym
Evaluation of gastrointestinal opportunistic infections in patients using steroids
Scientific Title
Evaluation of gastrointestinal oppotunistic infections in patients using steroids
Scientific Title:Acronym
Evaluation of gastrointestinal opportunistic infections in patients using steroids
Region
| Japan |
Condition
Condition
Patients using steroids
Classification by specialty
| Medicine in general | Gastroenterology | Clinical immunology |
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation between the occurrence of gastrointestinal opportunistic infections and clinical findings
Basic objectives2
Others
Basic objectives -Others
To clarify the endoscopic findings of gastrointestinal opportunistic infections
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical data on types, consumption, Period of steroid use, underlying disease, symptoms, and usage history of immunosuppressants among the presence of gastrointestinal opportunistic infections (candidasis, Cytomegalovirus, mycobacteria)
Key secondary outcomes
Endosocpic findings of gastrointestinal opportunistic infections
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with adminstration of steroids internally or intravenously at more than 2weeks
Key exclusion criteria
Patients with history of gastric rection
Patients with HIV and HTLV-1 infection
Patients with Primary Immunodeficiency Syndrome
Patients with severe liver and renal disfancction
In cases when previous information of gastrointestinal lesion is known
Patients with anti-CMV medication and antibacterial drug with 4 weeks
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Uemura |
Organization
International Medical Center of Japan
Division name
Gastroenterology
Zip code
Address
1-21-1 Toyama Shinjyuku-ku Tokyo Japan
TEL
03-3202-7181
gastriccarcinoma@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyoshi Nagata |
Organization
International Medical Center of Japan
Division name
Gastroenterology
Zip code
Address
1-21-1, Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
gastriccarcinoma@yahoo.co.jp
Sponsor or person
Institute
International Medical Center of Japan
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
国立国際医療センター
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 10 | 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
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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2009 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003498
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
