UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040990
Receipt number R000046801
Scientific Title Evaluation of clinical usefulness of a novel pancreatic cancer marker
Date of disclosure of the study information 2020/07/06
Last modified on 2020/07/02 20:28:53

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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 or person

Institute

Yokohama City University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046801


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name