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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010618
Receipt No. R000012417
Scientific Title Cancer Risk Associated with Anti-diabetic Medication - Valid Evaluation of Research questions by the Diabetes Institutes Collaborative Team
Date of disclosure of the study information 2013/05/06
Last modified on 2018/01/26

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Basic information
Public title Cancer Risk Associated with Anti-diabetic Medication - Valid Evaluation of Research questions by the Diabetes Institutes Collaborative Team
Acronym C-VERDICT
Scientific Title Cancer Risk Associated with Anti-diabetic Medication - Valid Evaluation of Research questions by the Diabetes Institutes Collaborative Team
Scientific Title:Acronym C-VERDICT
Region
Japan

Condition
Condition Diabetes Mellitus
Cancer
Classification by specialty
Medicine in general Endocrinology and Metabolism Hematology and clinical oncology
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the risk of cancer associated with different types of anti-diabetic medication.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Odds ratio of cancer incidence per oral hypoglycemic agent
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who meet all the following criteria. Only solid cancers are included;carcinoma in situ is included;precancerous lesion is not included. The diagnosis of cancer is according to physician's clinical judgment documented in medical records.
1) Type 2 diabetes mellitus that was diagosed in reference to the criteria by the Japan Diabetes Society, physician's judgement or self-report.
2) Japanese subjects 18 years of age or older.
3) Using any anti-diabetic agent at the time of cancer diagnosis (those only using insulin can also be registered).
4) Duration of diabetes 3 years or longer at the time of cancer diagnosis (if a subject had visited the clinic for shorter than 3 years, the medications given at the prior clinic need to be documented).
5) (cases) Those who have been visiting clinics and have been diagnosed of having cancer since January 2010.
6) (controls) Those who have been visiting clinics and have not been diagnosed of having cancer since January 2010.
Key exclusion criteria Those who meet any of the following criteria.
1) (cases) Cancer diagnosis within 3 years of the initiation of diabetes treatment.
2) Pregnancy during the past 3 years of cancer diagnosis.
3) Taking only diet therapy at the time of cancer diagnosis
4) Ever treated overseas during the past 3 years of cancer diagnosis.
Target sample size 1140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Noto
Organization National Center fo Global Health and Medicine
Division name Dept of Diabetes and Metabolic Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku, Tokyo162-8655, Japan
TEL 03-3202-7181
Email noto-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Noto
Organization National Center fo Global Health and Medicine
Division name Dept of Diabetes and Metabolic Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku, Tokyo162-8655, Japan
TEL 03-3202-7181
Homepage URL
Email noto-tky@umin.net

Sponsor
Institute National Center fo Global Health and Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 06 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
2013 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case-control study

Management information
Registered date
2013 Year 04 Month 30 Day
Last modified on
2018 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012417

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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