Resectable and unresectable pancreatic cancer
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTaro Shibuki
National Cancer Center Hospital East Department of Hepatobiliary and Pancreatic Oncology
Outcome results
None listed