UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010618 |
|---|---|
| Receipt number | 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 13:49:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
noto-tky@umin.net
Sponsor or person
Institute
National Center fo Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
