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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011426
Receipt No. R000013374
Scientific Title Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-
Date of disclosure of the study information 2013/08/13
Last modified on 2013/08/08

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Basic information
Public title Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-
Acronym Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-
Scientific Title Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-
Scientific Title:Acronym Epidemiology of Kala-Azar (Visceral Leishmaniasis) and Post-Kala-Azar Dermal Leishmaniasis in Bangladesh -A Prospective Cohort Study-
Region
Asia(except Japan)

Condition
Condition Kala-azar (visceral leishmaniasis) and post-kala-azar dermal leishmaniasis
Classification by specialty
Medicine in general Nephrology Infectious disease
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Kala-azar (visceral leishmaniasis) and post-kala-azar dermal leishmaniasis are prevalent in Bangladesh. However, the epidemiology of these diseases, especially in terms of diagnosis, treatment, and outcome, has not yet been fully elucidated. The aim of this study is therefore to improve understanding of these diseases by creating a database.
Basic objectives2 Others
Basic objectives -Others Epidemiology (no experimental intervention)
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Short- and long-term patient outcomes (1 month to 3 years) by treatment plan, especially the onset of post-kala-azar dermal leishmaniasis
Key secondary outcomes 1.Details of patient background, history, subjective symptoms, and objective findings at the time of diagnosis
2.Assessing the diagnostic effectiveness of serum and urine biomarkers

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who visit the participating facilities and are diagnosed with kala-azar (visceral leishmaniasis) or post-kala-azar dermal leishmaniasis
Key exclusion criteria Patients who refuse to participate in this observational study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eisei Noiri
Organization The University of Tokyo Hospital
Division name Department of Hemodialysis and Apheresis
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL +81-3-5800-8648
Email

Public contact
Name of contact person
1st name
Middle name
Last name Eisei Noiri
Organization The University of Tokyo Hospital
Division name Department of Hemodialysis and Apheresis
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL +81-3-5800-8648
Homepage URL http://satreps-kalaazar.com/index.html
Email Noiri-tky@umin.ac.jp

Sponsor
Institute Science and Technology Research Partnership for Sustainable Development (SATREPS)
Institute
Department

Funding Source
Organization Department of Hemodialysis and Apheresis, the University of Tokyo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Suruya Kanta Kala-azar Research Center (SKKRC) in Bangladesh
Name of secondary funder(s) None

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 Suruya Kanta Kala-azar Research Center(SKKRC)in Bangladesh

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 13 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
2013 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patient Background Data
History
Subjective Symptoms
Objective Findings
Physical Examination
Laboratory and Physiological Tests
Treatment Plan
One-month follow-up
Six-month follow-up
one-year follow-up
Two-year follow-up
Three-year follow-up

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2013 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013374

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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