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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002868
Receipt No. 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 2014/07/02

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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
Email 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
Email gastriccarcinoma@yahoo.co.jp

Sponsor
Institute International Medical Center of Japan
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
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
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2009 Year 12 Month 10 Day
Last modified on
2014 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003498

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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