UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A tumor-associated glycoprotein as a novel serological marker for pancreatic cancer: the confirmatory clinical study
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Keisuke Taniuchi
Organization	Kochi Medical School Hospital, Kochi University
Division name	Department of Gastroenterology and Hepatology
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	088-880-2339
Email	ktaniuchi@kochi-u.ac.jp

Public contact
Name of contact person	Keisuke Taniuchi
Organization	Kochi Medical School Hospital, Kochi University
Division name	Department of Gastroenterology and Hepatology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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