A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer

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 Type: Observational
• Enrollment (Estimated): 276

Contacts and Locations

• Study Contact: Name: Xian-Jun Yu, M.D., Ph.D.; Phone Number: +86 21 64175590; Email: yuxianjun@fudanpci.org
• Study Contact Backup: Name: Si Shi, M.D., Ph.D.; Phone Number: +86 21 64175590

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Department of Biliary Pancreatic Surgery, Shanghai Changzheng Hospital, The Second Military Medical University
      • Contact: Cheng-Hao Shao, M.D PH.D; Phone Number: 021-81886999; Email: schhao88@gmail.com
      • Principal Investigator: Cheng-Hao Shao, M.D PH.D
    • Shanghai, Shanghai, China, 200032
      • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
      • Principal Investigator: Xianjun Yu, M.D., Ph.D.
      • Contact: Xian-Jun Yu, M.D., Ph.D.; Phone Number: +86-21-6417-5590; Email: yuxianjun@fudanpci.org
      • Contact: M.D., Ph.D.
    • Shanghai, Shanghai, China
      • Department of General Sugery, Huadong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed pancreatic cancer or pancreatic non-malignant disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cancer arm; Participants with new diagnosis of pancreatic cancer, from whom a peripheral blood sample will be collected.
Benign disease arm; Participants with benign pancreatic diseases, from whom a peripheral blood sample will be collected.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Shanghai Weihe Medical Laboratory Co., Ltd.
• Investigators: Study Chair: Xian-Jun Yu, M.D., Ph.D., Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): December 22, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: Profound-PC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No