UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021938 |
|---|---|
| Receipt number | R000025258 |
| Scientific Title | A tumor-associated glycoprotein as a novel serological marker for pancreatic cancer: the confirmatory clinical study |
| Date of disclosure of the study information | 2016/04/16 |
| Last modified on | 2016/04/18 13:20:55 |
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Basic information
Public title
A tumor-associated glycoprotein as a novel serological marker for pancreatic cancer: the confirmatory clinical study
Acronym
A novel serological marker for pancreatic cancer
Scientific Title
A tumor-associated glycoprotein as a novel serological marker for pancreatic cancer: the confirmatory clinical study
Scientific Title:Acronym
A novel serological marker for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to assess the utility of serum 2 glycoproteins and 6 RNAs as diagnostic markers for differentiating pancreatic cancer and IPMN from individuals without pancreatic disorders. The primary endpoint is to assess whether a glycoprotein IGFP is more useful to diagnose pancreatic cancer and IPMN, compared with CA19-9.
Basic objectives2
Others
Basic objectives -Others
Confirmation of the diagnostic ability
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the area under the curve (AUC) of Reciever Operating Characteristic Curves (ROC curves) between IGFP and CA19-9
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) more than 20 years old and less than 90 years old
(2) pancreatic cancer patients and IPMN patients newly diagnosed and previously untreated
(3) all individuals classified as controls are diagnosed as chronic hepatitis or gastrointestinal diseases with being evaluated for non-pancreatic diseases.
Key exclusion criteria
(1) pancreatic cancer patients and IPMN patients previously treated
(2) patients who were suffering from any kind of malignancies including pancreatic cancer
(3) sever renal or liver dysfunction
(4) individuals who did not accept informed consent
(5) unsuitable individuals for this clinical study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Taniuchi |
Organization
Kochi Medical School Hospital, Kochi University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-880-2339
ktaniuchi@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Taniuchi |
Organization
Kochi Medical School Hospital, Kochi University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-880-2339
Homepage URL
ktaniuchi@kochi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kochi Health Sciences Center
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
| 2016 | Year | 04 | Month | 16 | 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
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The identification code is given to individuals, and the data is resisted into EDC system (REDcap).
Management information
Registered date
| 2016 | Year | 04 | Month | 16 | Day |
Last modified on
| 2016 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025258
