Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
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. Using tumor tissue, a personalized blood test (the Invitae Personalized Cancer MonitoringTM test) will be developed that can be used for repeated monitoring to assess for the presence or absence of circulating tumor DNA (ctDNA). The presence of residual cancer cells after treatment is known as molecular residual disease (MRD) and the detection of ctDNA can provide evidence of the presence of MRD. Participants in this study will have their blood drawn at various time points throughout their cancer treatment to test for ctDNA and monitoring with the Invitae Personalized Cancer MonitoringTM test will continue until disease progression or the duration of the study.
• 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