UMIN-CTR Clinical Trial

Public title

Diagnosis of cases of early recurrence after resection of pancreatic cancer

Acronym

Diagnosis of cases of early recurrence after resection of pancreatic cancer

Scientific Title

Development of a diagnostic method for high-risk cases of early postoperative recurrence of pancreatic cancer using temporal exosome analysis

Scientific Title:Acronym

Development of a diagnostic method for high-risk cases of early postoperative recurrence of pancreatic cancer using temporal exosome analysis

Region

Japan

Condition

pancreatic ductal adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

In this study, we will analyze microRNAs (miRs) encapsulated in exosomes over time before and after surgery and perioperative chemotherapy, and prospectively analyze the relationship between specific miRs, recurrence type, and prognosis to determine whether it is possible to predict high-risk cases of early postoperative recurrence of pancreatic cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Identification of miRs associated with early recurrence

Key secondary outcomes

Relationship between candidate miRs and prognosis

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

90

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients who have been or will be treated for pancreatic cancer at our hospital
2)Age 20 years or older
3) Patients who are able to collect new peripheral blood (10ml)
4) Patients who have sufficient judgment to understand the contents of the study and have given written consent.

Key exclusion criteria

None in particular

Target sample size

100

Name of lead principal investigator

1st name	Masafumi
Middle name
Last name	Imamura

Organization

Sapporo Medical University

Division name

Department of Surgery, Surgical Oncology and Science

Zip code

0608543

Address

South 1, West 16, Chuo-ku, Sapporo

TEL

0116112111

Email

imamura@sapmed.ac.jp

Name of contact person

1st name	Masafumi
Middle name
Last name	Imamura

Organization

Sapporo Medical University

Division name

Department of Surgery, Surgical Oncology and Science

Zip code

0608543

Address

South 1, West 16, Chuo-ku, Sapporo

TEL

0116112111

Homepage URL

Email

imamura@sapmed.ac.jp

Institute

Sapporo Medical University

Institute

Department

Personal name

Organization

Japan Society for the promotion of science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Sapporo Medical University Hospital

Address

South 1, West 16, Chuo-ku, Sapporo

Tel

0116112111

Email

rinri@sapmed.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

08

Month

10

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

Enrolling by invitation

Date of protocol fixation

2020

Year

05

Month

14

Day

Date of IRB

2020

Year

06

Month

11

Day

Anticipated trial start date

2020

Year

06

Month

11

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Retrospective study of postoperative patients with pancreatic cancer
We will perform a comprehensive analysis of miRs using microarrays on 5 recurrence cases and 5 recurrence-free cases (10 cases in total) to examine candidate genes. Based on the results, miR expression will be analyzed using the Realtime-PCR method to identify miRs associated with recurrence.

2. Prospective study of patients scheduled for resection of pancreatic cancer
The expression of candidate miRs will be analyzed over time before and after surgery. Candidate miRs will be contrasted with clinical data (stage, presence of recurrence, recurrence type, and prognosis). To evaluate early recurrence, patients will be seen every month for 1 year after surgery, and blood tests including tumor markers (CEA, CA19-9, DUPAN2) will be performed every time. The relationship between candidate miRs and prognosis will be statistically analyzed using the Kaplan-Meier method and Cox proportional hazards model to verify whether early recurrence is predictable or not. Tumor markers and imaging are currently the only means to depict recurrence, but we will examine whether or not the candidate miRs in exosomes change prior to these tests.

Registered date

2021

Year

08

Month

10

Day

Last modified on

2021

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051535