Multi-omics Model for Pancreatic Cancer Screening Using cfDNA

NCT06456281 | Recruiting

• 1 other identifier: P04UR086-PAAD
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Performance of cfDNA multi-omics model 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.

  12 months

• Performance of pre-defined model in clinical sub-groups of interest.

  12 months

Study Arms (3)

Cancer arm

Participants with new diagnosis of pancreatic cancer.

Diagnostic Test: A noninvasive cfDNA multi-omics assay

Precancerous lesions arm

Participants with precancerous lesions.

Diagnostic Test: A noninvasive cfDNA multi-omics assay

Healthy individuals arm

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

Diagnostic Test: A noninvasive cfDNA multi-omics assay

Interventions

A noninvasive cfDNA multi-omics assay DIAGNOSTIC_TEST

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 capture-based targeted methylation sequencing (TMS).

Cancer arm; Healthy individuals arm; Precancerous lesions arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed pancreatic cancer or precancerous lesions and healthy individuals.

You may qualify if:

• 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

You may not qualify if:

• 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
• Precancerous Lesions Arm
• 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

Sponsors & Collaborators

• Fudan University: lead
• Nanjing Simcere Medical Laboratory Science Co., Ltd.: collaborator

Study Sites (1)

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Xian-Jun Yu, M.D., Ph.D.

CONTACT

+86-21-64175590; yuxianjun@fudanpci.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: June 28, 2024
• Primary Completion: March 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)