Multi-omics Model for Pancreatic Cancer Screening Using cfDNA

NCT ID: NCT06456281

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2025-12-30

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer arm

Participants with new diagnosis of pancreatic cancer.

A noninvasive cfDNA multi-omics assay

Intervention Type: 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).

Precancerous lesions arm

Participants with precancerous lesions.

A noninvasive cfDNA multi-omics assay

Intervention Type: 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).

Healthy individuals arm

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

A noninvasive cfDNA multi-omics assay

Intervention Type: 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).

Interventions

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 capture-based targeted methylation sequencing (TMS).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• 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

• 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

Precancerous Lesions Arm

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Simcere Medical Laboratory Science Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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, China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

yuxianjun@fudanpci.org

+86-21-64175590

Facility Contacts

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

Role: primary

yuxianjun@fudanpci.org

+86-21-64175590

Other Identifiers

P04UR086-PAAD

Identifier Type: -

Identifier Source: org_study_id