UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043561 |
|---|---|
| Receipt number | R000049738 |
| Scientific Title | Multicenter Study of Circulating Tumor DNA in Patients with Pancreatic Cancer Using a Personalized Panel |
| Date of disclosure of the study information | 2021/03/09 |
| Last modified on | 2025/03/12 10:25:39 |
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Basic information
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
Condition
Resectable and unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1.Cohort of patients with unresectable pancreatic cancer
To Evaluate the positivity rate of ctDNA by Invitae PCM.
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
Assessment
Primary outcomes
1.Cohort of patients with unresectable pancreatic cancer
Pre-treatment ctDNA identification rate
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.
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
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
Research contact person
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
masikeda@east.ncc.go.jp
Public contact
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
tshibuki@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Invitae Corporation
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1,tsukiji,chuo-ku,Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2021 | Year | 03 | Month | 09 | 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
No longer 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
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049738
