UMIN-CTR Clinical Trial

Public title

Multicenter Study of Circulating Tumor DNA in Patients with Pancreatic Cancer Using a Personalized Panel

Acronym

ARTEMIS-PC

Scientific Title

Multicenter Study of Circulating Tumor DNA in Patients with Pancreatic Cancer Using a Personalized Panel

Scientific Title:Acronym

ARTEMIS-PC

Region

Japan

Condition

Resectable and unresectable pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

1.Cohort of patients with unresectable pancreatic cancer
To evaluate the rate of concordance of KRAS mutations between tumor tissue specimens and blood samples.

2.Cohort of patients with resectable pancreatic cancer
To evaluate the success rate of creation of a personalized panel using tumor tissue specimens obtained by EUS-FNA/FNB

Basic objectives2

Others

Basic objectives -Others

1.Cohort of patients with unresectable pancreatic cancer
Pretreatment ctDNA detection rate for each disease stage (stage III and stage IV)
Association of pretreatment ctDNA detection rate and the treatment efficacy
Differences in OS and PFS between the patients in whom the personalized panel can be created and those in whom it cannot be created

2.Cohort of patients with resectable pancreatic cancer
Rate of ctDNA positivity for each cancer stage (stage IA-stage IIB) before neoadjuvant chemotherapy (NAC) and 4 weeks after surgery.
Differences in OS and PFS between the patients in whom the personalized panel can be created and those in whom it cannot be created
To investigate the lead time from ctDNA detection to recurrence detected by diagnostic imaging.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1.Cohort of patients with unresectable pancreatic cancer
Rate of concordance of KRAS mutations between tumor tissue and blood samples as determined

2.Cohort of patients with resectable pancreatic cancer
Success rate of creation of a personalized panel using tumor tissue specimens obtained by EUS-FNA/FNB

Key secondary outcomes

1.Cohort of patients with unresectable pancreatic cancer
Pretreatment ctDNA detection rate for each disease stage (stage III and stage IV)
Association of pretreatment ctDNA detection rate and the treatment efficacy
Association of pretreatment serum tumor marker levels, ctDNA levels and treatment efficacy
Association of the time-course of changes of the pretreatment serum tumor marker levels and ctDNA positivity and the treatment efficacy
Differences in OS and PFS between the patients in whom the personalized panel can be created and those in whom it cannot be created

2.Cohort of patients with resectable pancreatic cancer
Rate of ctDNA positivity for each cancer stage (stage IA-stage IIB) before neoadjuvant chemotherapy (NAC) and 4 weeks after surgery.
Association of preoperative ctDNA before NAC and overall survival
Association of postoperative ctDNA before adjuvant chemotherapy (AC) and overall survival
Proportion of ctDNA positivity at the time of recurrence detected by diagnostic imaging.
Association of serum tumor marker levels and recurrence free survival (RFS), ctDNA positivity an d RFS at the timepoints before NAC and before AC.
Differences in OS and PFS between the patients in whom the personalized panel can be created and those in whom it cannot be created
To investigate the lead time from ctDNA detection to recurrence detected by diagnostic imaging.

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

I.Cohort of patients with unresectable pancreatic cancer
1.At least 20 years of age at the time of consent.
2.Histopathologically confirmed adenocarcinoma and diagnosed as having a or b described below within 60 days prior to enrollment.
a.Clinical Stage 3 (T1-3N2M0, T4 anyNM0)
b.Clinical Stage 4 (anyTanyNM1)
3.Scheduled to receive systemic chemotherapy for unresectable pancreatic cancer.
4.No prior treatment for pancreatic cancer.
5.Willing to provide blood and tissue samples in accordance with the research protocol.
6.Adequate tissue samples are available.
7.Written informed consent for participating in this study

II.Cohort of patients with resectable pancreatic cancer
1.At least 20 years of age at the time of consent.
2.Tissue sample collected by EUS-FNA/FNB and histopathologically diagnosed as having adenocarcinoma.
3.Diagnosed as having cancer meet any one of a to d below within 60 days prior to enrollment.
a.cStage IA (T1 N0 M0)
b.cStage IB (T2 N0 M0)
c.cStage IIA (T3 N0 M0)
d.cStage IIB (T1-3 N1 M0)
4.Scheduled to undergo surgery for resectable pancreatic cancer.
5.No history of prior treatment for pancreatic cancer.
6.Willing to submit blood and tissue samples in accordance with the research protocol.
7.Adequate tissue samples are available
8.Written informed consent for participating in this study

Key exclusion criteria

Common exclusion criteria for both the unresectable and resectable pancreatic cancer patient cohorts
1.Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 2 years or shorter.
2.Women who are pregnant or planning to become pregnant.
3.Judged by the investigator as being unsuitable for participation in the study.

Target sample size

150

Name of lead principal investigator

1st name	Masafumi
Middle name
Last name	Ikeda

Organization

National Cancer Center Hospital East

Division name

Department of Hepatobiliary and Pancreatic Oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba

TEL

04-7133-1111

Email

masikeda@east.ncc.go.jp

Name of contact person

1st name	Taro
Middle name
Last name	Shibuki

Organization

National Cancer Center Hospital East

Division name

Department of Hepatobiliary and Pancreatic Oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba

TEL

04-7133-1111

Homepage URL

Email

tshibuki@east.ncc.go.jp

Institute

National Cancer Center Hospital East

Institute

Department

Personal name

Organization

Invitae Corporation

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

USA

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1,tsukiji,chuo-ku,Tokyo

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.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

03

Month

09

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

Open public recruiting

Date of protocol fixation

2021

Year

03

Month

09

Day

Date of IRB

2021

Year

05

Month

18

Day

Anticipated trial start date

2022

Year

11

Month

28

Day

Last follow-up date

2026

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

none

Registered date

2021

Year

03

Month

09

Day

Last modified on

2023

Year

03

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049738