UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of clinical usefulness of a novel pancreatic cancer marker
Acronym	Evaluation of clinical usefulness of a novel pancreatic cancer marker
Scientific Title	Evaluation of clinical usefulness of a novel pancreatic cancer marker
Scientific Title:Acronym	Evaluation of clinical usefulness of a novel pancreatic cancer marker
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	To evaluate the clinical diagnostic performance of tissue factor pathway inhibitor-2 (TFPI2) in preoperative prediction of pancreatic cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the clinical diagnostic performance of TFPI2 in patients with pancreatic cancer (diagnostic accuracy, sensitivity, sensitivity, ROC curve analysis, area under the ROC curve)
Key secondary outcomes	To evaluate the complementarity between TFPI2 and conventional markers (CEA, CA19-9, DUPAN-2, SPAN-1). To investigate relation between TFPI2 and thrombosis (D-dimer or imge findings).

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with pancreatic disease (inflammation, benign or malignant) who are admitted to Yokohama City University Hospital within the study period and judged to be suitable for this study. 2. Patients planed to undergo surgery (including trial laparotomy) or chemo (radiation) therapy as initial treatments (including patients who do not require therapeutic intervention for inflammatory and benign diseases). 3. Written informed consent. 4. Age over 20.
Key exclusion criteria	1.Patients with simultaneous or metachronous double cancer. 2.Samples taken from patients who is considered inappropriate for the inclusion by the responsible physician of each institution. 3. Patients who are pregnant or may be pregnant at the time of blood collection.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Itaru Middle name Last name Endo
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2800
Email	endoit@med.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Shimizu
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-787-2800
Homepage URL
Email	yshimizu@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	TOSOH CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9 Fukuura Kanazawa-Ku Yokohama
Tel	045-370-7627
Email	rinri@yokohama-cu.ac.jp

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	2020 Year 07 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	Enrolling by invitation
Date of protocol fixation	2020 Year 01 Month 14 Day
Date of IRB	2020 Year 01 Month 14 Day
Anticipated trial start date	2020 Year 07 Month 06 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Analysis of changes in TFPI2 before and after treatment (chemotherapy, surgery)

Management information
Registered date	2020 Year 07 Month 02 Day
Last modified on	2020 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046801