UMIN-CTR Clinical Trial

Public title

A minimally invasive test for
diagnosis of pancreatic neoplasm
using cell-free nucleic acid and residual specimens

Acronym

A minimally invasive test for
diagnosis of pancreatic neoplasm

Scientific Title

A minimally invasive test for
diagnosis of pancreatic neoplasm
using cell-free nucleic acid and residual specimens

Scientific Title:Acronym

A minimally invasive test for
diagnosis of pancreatic neoplasm

Region

Japan

Condition

Patients with pancreatic cancer and
its precancerous lesions, and
individuals at high risk of developing
pancreatic neoplasm, and patients
with benign gastrointestinal
disorders such as cholelithiasis and
gastroduodenal ulcer

Classification by specialty

Hepato-biliary-pancreatic medicine

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To examine the efficacy and
feasibility of the quantitative
detection of tumor-associated nucleic
acid in the body fluid, including blood
and pancreatic juice collected from the duodenum,
and residual tissue specimens for
diagnosis of pancreatic neoplasm.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Diagnostic value of quantitative
detection and monitoring of
tumor-associated alterations
in circulating cell-free nucleic acid
and tissue-derived nucleic acid
for the diagnosis of pancreatic neoplasm.

Key secondary outcomes

Surveillance of individuals at high
risk of developing pancreatic
neoplasm by quantitative detection
and monitoring of tumor-associated
alterations in cell-free nucleic
acid and tissue-derived nucleic acid.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

･Patients with malignant pancreatic tumor
and benign/pre-cancerous lesions.
･Individuals at high risk of developing
pancreatic neoplasm.
･Patients with benign digestive disorder
who receive upper endoscopic examination.
･Patients with written informed consent.

Key exclusion criteria

･Patients with severe heart disease
･Patients with severe renal disease
･Patients with serious mental illness
･Patients complicated with severe
infection
･Patients with severe diabetes
･Patients with severe dehydration
and malnutrition
･Patients who have other serious
complications and are considered
difficult to participate
･Patient who judged inappropriate
by an attendant physician

Target sample size

400

Name of lead principal investigator

1st name	Yusuke
Middle name
Last name	Mizukami

Organization

Asahikawa Medical University

Division name

Cancer Genomics and Precision Medicine Department of Medicine

Zip code

0788510

Address

2-1 Midorigaoka Higashi, Asahikawa,Hokkaido 078-8510

TEL

0166-68-2462

Email

mizu@asahikawa-med.ac.jp

Name of contact person

1st name	Yusuke
Middle name
Last name	Mizukami

Organization

Asahikawa Medical University

Division name

Cancer Genomics and Precision Medicine Department of Medicine

Zip code

0788510

Address

2-1 Midorigaoka Higashi, Asahikawa,Hokkaido 078-8510

TEL

0166-68-2462

Homepage URL

Email

mizu@asahikawa-med.ac.jp

Institute

Asahikawa Medical University

Institute

Department

Personal name

Organization

Hitachi High-Tech Corporation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Sapporo Higashi Tokushukai Hospital
Asahikawa-Kosei General Hospital
Japanese Red Cross Asahikawa Hospital
Shibetsu City Hospital
Teine Keijinkai Hospital
Engaru-Kosei General Hospital

Name of secondary funder(s)

Hitachi High-Tech Corporation

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

旭川医科大学（北海道）

Date of disclosure of the study information

2017

Year

07

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

06

Month

08

Day

Date of IRB

2022

Year

11

Month

29

Day

Anticipated trial start date

2017

Year

06

Month

20

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

None

Registered date

2017

Year

07

Month

19

Day

Last modified on

2023

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032379