A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay

Conditions
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Pancreatic Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer arm<br>Participants with new diagnosis of pancreatic cancer, from whom a peripheral blood sample will be collected. | |
| Benign disease arm<br>Participants with benign pancreatic diseases, from whom a peripheral blood sample will be collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer | Sensitivities of cfDNA methylation-based model at specificity of 99% and 95%, respectively. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer | Sensitivities of model integrating multi-omics data at specificity of 99% and 95%,respectively. | 12 months | 
| Performance of pre-defined model in clinical sub-groups of interest | Sensitivity of pre-defined model in different pathological subtypes or different age groups or tumor marker-negative cases. | 12 months |