UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005043 |
|---|---|
| Receipt number | R000004973 |
| Scientific Title | A randomized phase II study of comparing every 3 months- or six months-screening examination for the diagnosis of pancreatic cancer |
| Date of disclosure of the study information | 2011/02/07 |
| Last modified on | 2019/02/18 11:03:39 |
* 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
A randomized phase II study of comparing every 3 months- or six months-screening examination for the diagnosis of pancreatic cancer
Acronym
RCT for screening of PC
Scientific Title
A randomized phase II study of comparing every 3 months- or six months-screening examination for the diagnosis of pancreatic cancer
Scientific Title:Acronym
RCT for screening of PC
Region
| Japan |
Condition
Condition
Patients with main pancreatic duct dilatation and/or pancreatic cyst
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine effective periodic checkup for the early diagnosis of pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
early pancreatic cancer rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
every three months examination
Interventions/Control_2
every six months examination
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of age =>35 and 75>
Written informed consent.
Key exclusion criteria
Performance Status=<2
poor study of US
Patients with active synchronous or metachronous malignancy
drug allergy of iodine
Patients with kidney damage
Patients who are pregnant or have an intention to get pregnant
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ioka |
Organization
Osaka Medical Center fo Cancer and CVD
Division name
Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address
Nakamichi 1-3-3, Higashinari-ku, Osaka, 5378511, Japan
TEL
06-6945-1181
ioka_ta@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ioka |
Organization
Osaka Medical Center fo Cancer and CVD
Division name
Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address
Nakamichi 1-3-3, Higashinari-ku, Osaka, 5378511, Japan
TEL
06-6945-1181
Homepage URL
ioka_ta@hotmail.com
Sponsor or person
Institute
Osaka Medical Center fo Cancer and CVD
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefecture
Organization
Division
Category of Funding Organization
Local Government
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
| 2011 | Year | 02 | Month | 07 | 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
| 2009 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004973
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
