Multi-omics Model for Pancreatic Cancer Screening Using cfDNA

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Diagnostic Test: A noninvasive cfDNA multi-omics assay

• Registration Number: NCT06456281
• Lead Sponsor: Fudan University

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Submitted: 2024-06-27
• Study Start: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-03-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Healthy Individuals Arm

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Precancerous lesions arm	A noninvasive cfDNA multi-omics assay	Participants with precancerous lesions.
Healthy individuals arm	A noninvasive cfDNA multi-omics assay	Healthy individuals without findings of clinical significance during routine health checkups.
Cancer arm	A noninvasive cfDNA multi-omics assay	Participants with new diagnosis of pancreatic cancer.

Primary Outcome Measures

Name	Time	Method
Performance of cfDNA multi-omics model for discriminating pancreatic cancer versus healthy individuals.	12 months	The area under the curve (AUC), sensitivity and specificity of cfDNA multi-omics model.

Secondary Outcome Measures

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

Trial Locations

Locations (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, China