UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002884 |
|---|---|
| Receipt number | R000003520 |
| Scientific Title | Retrospective study for significance of polymorphisms of UGT1A1 for Irinotecan toxicities in advanced cancer patients who received Irinotecan chemotherapy |
| Date of disclosure of the study information | 2010/01/25 |
| Last modified on | 2019/01/16 15:39:08 |
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Basic information
Public title
Retrospective study for significance of polymorphisms of UGT1A1 for Irinotecan toxicities in advanced cancer patients who received Irinotecan chemotherapy
Acronym
Retrospective study of polymorphisms of UGT1A1 and Irinotecan toxicities
Scientific Title
Retrospective study for significance of polymorphisms of UGT1A1 for Irinotecan toxicities in advanced cancer patients who received Irinotecan chemotherapy
Scientific Title:Acronym
Retrospective study of polymorphisms of UGT1A1 and Irinotecan toxicities
Region
| Japan |
Condition
Condition
advanced cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To observe and clarify the association between polymorphisms of UGT1A1 and severe adverce effects of Irinotecan in Japanese advanced cancer patients
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Severe adverse effects of grade 3 or severer neutropenia and/or diarrhea after receiving Irinotecan containing chemotherapy
Key secondary outcomes
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
Advenced cancer patients who received Irinotecan containing chemotherapy
Key exclusion criteria
n/a
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikashi Ishioka |
Organization
Tohoku University Hospital
Division name
Clinical Oncology
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-8543
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoko Akiyama |
Organization
Tohoku University Hospital
Division name
Clinical Oncology
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-8543
Homepage URL
http://www.med.tohoku.ac.jp/public/ekigaku.html
s-ikeda@idac.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Retrospective study for the connection of severe adverse effects by Irinotecan and polymorphisms of UGT1A1 in advanced cancer patients who received Irinotecan containing chemotherapy
Management information
Registered date
| 2009 | Year | 12 | Month | 12 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003520
| 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 |
