Multi-omics Model For Pancreatic Cancer Screening Using CfDNA

Study Overview

Multi-omics Model for Pancreatic Cancer Screening Using cfDNA

This is a prospective case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer.

Peripheral blood samples from participants with new diagnosis of pancreatic cancers, precancerous lesions and healthy individuals will be collected to characterize the cancer-specific signatures by low-pass whole-genome sequencing and target methylation sequencing using cfDNA. An ensemble multi-omics model will be trained aided by machine learning algorithm and validated in test set. The performance of this multi-omics model distinguishing pancreatic cancer from non-cancer will be evaluated.

Pancreatic Cancer

DIAGNOSTIC_TEST: A noninvasive cfDNA multi-omics assay

P04UR086-PAAD

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 2024-06-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-06-27
First Submitted that Met QC Criteria 2024-06-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-01
First Posted (ACTUAL) 2024-06-13	Results First Posted N/A	Last Verified 2024-06

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.	DIAGNOSTIC_TEST: A noninvasive cfDNA multi-omics assay Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid cap
: Precancerous lesions arm Participants with precancerous lesions.	DIAGNOSTIC_TEST: A noninvasive cfDNA multi-omics assay Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid cap
: Healthy individuals arm Healthy individuals without findings of clinical significance during routine health checkups.	DIAGNOSTIC_TEST: A noninvasive cfDNA multi-omics assay Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid cap

Participant Group/Arm

Intervention/Treatment

: Cancer arm

Participants with new diagnosis of pancreatic cancer.

DIAGNOSTIC_TEST: A noninvasive cfDNA multi-omics assay

Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid cap

: Precancerous lesions arm

Participants with precancerous lesions.

DIAGNOSTIC_TEST: A noninvasive cfDNA multi-omics assay

Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid cap

: Healthy individuals arm

Healthy individuals without findings of clinical significance during routine health checkups.

DIAGNOSTIC_TEST: A noninvasive cfDNA multi-omics assay

Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid cap

Primary Outcome Measures	Measure Description	Time Frame
Performance of cfDNA multi-omics model for discriminating pancreatic cancer versus healthy individuals.	The area under the curve (AUC), sensitivity and specificity of cfDNA multi-omics model.	12 months

Secondary Outcome Measures	Measure Description	Time Frame
Performance of cfDNA multi-omics model for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals.	Sensitivity of cfDNA multi-omics model at specificity of 95% for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals.	12 months
Performance of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals.	Sensitivity of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals.	12 months
Performance of pre-defined model in clinical sub-groups of interest.	Sensitivity of cfDNA multi-omics model for pancreatic cancer at different stages or in different pathological subtypes.	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

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:
18 Years

Accepts Healthy Volunteers:
1

18-75 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
Physical status score ECOG 0-1

Pregnancy or lactating women
Known prior or current diagnosis of other types of malignancies comorbidities
Severe acute infection or febrile illness 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

18-75 years old
Diagnosed with pancreatic intraepithelial tumor pancreatic intraepithelial lesions (PanINs), Intraductal papillary mucinous neoplasms (IPMN) or mucinous cystic neoplasms (MCN) by radiographical assess
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 or febrile illness 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

18-75 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 or febrile illness 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.

Nanjing Simcere Medical Laboratory Science Co., Ltd.

Investigators

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

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Clinical Trial Record