A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection

Not yet recruiting

• Conditions: Pancreatic Cancer

• Registration Number: NCT06166147
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-11-07
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Study Start: 2023-12-22
• Primary Completion: 2026-10-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer	12 months	Sensitivities of cfDNA methylation-based model at specificity of 99% and 95%, respectively.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Department of General Sugery, Huadong Hospital; 🇨🇳 Shanghai, Shanghai, China