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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021938
Receipt No. 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

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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
Email 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
Email ktaniuchi@kochi-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kochi Medical School, Kochi University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025258

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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