Status:
RECRUITING
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
Lead Sponsor:
Invitae Corporation
Collaborating Sponsors:
National Cancer Center Hospital East
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
20+ years
Brief Summary
This is a multicenter, prospective, observational study to evaluate the utility of the Invitae Personalized Cancer MonitoringTM assay for patients with resectable and unresectable pancreatic cancer. U...
Detailed Description
This is a multi-site, prospective, observational trial in Japan of 150 pts with resectable (50) and unresectable (100) PC. The main eligibility criteria are histopathologically diagnosed as adenocarci...
Eligibility Criteria
Inclusion
- A. Unresectable Pancreatic Cancer:
- At least 20 years of age at the time of consent
- Histopathologically confirmed adenocarcinoma and diagnosed as having ① or ② described below within 60 days prior to enrollment
- Clinical Stage Ⅲ (T1-3N2M0, T4 anyNM0)
- Clinical Stage Ⅳ (anyTanyNM1)
- Scheduled to receive systemic chemotherapy for unresectable pancreatic cancer.
- No prior treatment for pancreatic cancer
- Willing to provide blood and tissue samples in accordance with the research protocol.
- Adequate tissue samples are available
- Written informed consent for participating in this study
- B. Resectable Pancreatic Cancer:
- At least 20 years of age at the time of consent.
- Tissue sample collected by EUS-FNA/FNB and histopathologically diagnosed as having adenocarcinoma.
- Diagnosed as having cancer meet any one of a to d below within 60 days prior to enrollment
- cStage IA (T1 N0 M0)
- cStage IB (T2 N0 M0)
- cStage IIA (T3 N0 M0)
- cStage IIB (T1-3 N1 M0)
- Scheduled to undergo surgery for resectable pancreatic cancer.
- No history of prior treatment for pancreatic cancer.
- Willing to submit blood and tissue samples in accordance with the research protocol.
- Adequate tissue samples are available
- Written informed consent for participating in this study
Exclusion
- Common exclusion criteria for both the unresectable and resectable pancreatic cancer patient cohorts:
- Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 2 years or shorter.
- Women who are pregnant or planning to become pregnant.
- Judged by the investigator as being unsuitable for participation in the study.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06043921
Start Date
November 1 2022
End Date
December 1 2026
Last Update
September 21 2023
Active Locations (1)
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1
National Cancer Center Hospital East
Kashiwa, Japan