a prospective study of liquid biopsy for pancreatic cancer early detection

Conditions: Pancreatic Cancer

Summary: this study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated individuals.

peripheral blood samples from participants with new diagnosis of pancreatic cancers will be collected to characterize the cancer-specific circulating signals by sequencing cell free dna. a noninvasive test integrating machine learning algorithm will be trained and validated through a two-stage approach in recruited well-classified individuals, along with non-cancers without clinical diagnosis of cancer after routine medical screening. the performance of liquid biospy assays discovering cancer from non-cancer will be evaluated in participants with benign disease as well as average risk individuals.

Eligibility criteria:
cancer arm inclusion criteria: * 40-75 years old * clinically and/or pathologically diagnosed pancreatic cancer * no prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. * able to provide a written informed consent and willing to comply with all part of the protocol procedures. exclusion criteria: * pregnancy or lactating women * known prior or current diagnosis of other types of malignancies comorbidities * severe acute infection (e.g. severe or critical covid-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °c) within 14 days prior to blood draw * recipients of organ transplant or prior bone marrow transplant or stem cell transplant * recipients of blood transfusion within 30 days prior to study blood draw * recipients of therapy in past 14 days prior to blood draw, including oral or iv antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide * other conditions that the investigators considered are not suitable for the enrollment benign disease arm inclusion criteria: * 40-75 years old * clinically and/or pathologically diagnosed pancreatic non-malignant disease (pancreatic intraepithelial neoplasia, pancreatic cyst and chronic pancreatitis) * no prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. * able to provide a written informed consent and willing to comply with all part of the protocol procedures exclusion criteria: * pregnancy or lactating women * known prior or current diagnosis of other types of malignancies comorbidities * severe acute infection (e.g. severe or critical covid-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °c) within 14 days prior to blood draw * recipients of organ transplant or prior bone marrow transplant or stem cell transplant * recipients of blood transfusion within 30 days prior to study blood draw * recipients of therapy in past 14 days prior to blood draw, including oral or iv antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide * other conditions that the investigators considered are not suitable for the enrollment