A Prospective Study Of Liquid Biopsy For Pancreatic Cancer Early Detection

Study Overview

A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection

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.

Pancreatic Cancer

Profound-PC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-09-15
First Submitted that Met QC Criteria 2023-12-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-09-19
First Posted (ACTUAL) 2023-12-12	Results First Posted N/A	Last Verified 2024-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
40 Years

Accepts Healthy Volunteers:

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.

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Shanghai Weihe Medical Laboratory Co., Ltd.

Investigators

STUDY_CHAIR: Xian-Jun Yu, M.D., Ph.D., Fudan University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record