UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003652 |
|---|---|
| Receipt number | R000004422 |
| Scientific Title | Prospective cohort study of HCV infection and the risk of developement of maligant lymphoma |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2017/05/27 10:21:30 |
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Basic information
Public title
Prospective cohort study of HCV infection and the risk of developement of maligant lymphoma
Acronym
HCV infection and malignant lymphoma
Scientific Title
Prospective cohort study of HCV infection and the risk of developement of maligant lymphoma
Scientific Title:Acronym
HCV infection and malignant lymphoma
Region
| Japan |
Condition
Condition
hematopoietic malignancy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that HCV infection is associated with increased risk for malignant lymphoma in Japan.
Basic objectives2
Others
Basic objectives -Others
epidemiologic study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of the ratio of HCV infected population between malignant lymphoma and other hematopoietic malignancies.
Key secondary outcomes
The difference of HCV genotype between malignant lymphoma and other hematopoietic malignancies.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases who are newly diagnosed as malignant lymphomam, acute leukemia, plasma cell dyscrasia, myeloproliferative disorders, and myelodysplastic syndrome from July 2009.
Key exclusion criteria
not specified
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Nagai |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Clinical Research Center
Zip code
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Japan
TEL
052-951-1111
nagaih@nnh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Nagai |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Clinical Research Center
Zip code
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Japan
TEL
052-951-1111
Homepage URL
nagaih@nnh.hosp.go.jp
Sponsor or person
Institute
Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | 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
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
| 2009 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study.
Serial enrollment of newly diagnosed hematopoietic malignancies at registered sites from July 2010.
Management information
Registered date
| 2010 | Year | 05 | Month | 21 | Day |
Last modified on
| 2017 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004422
