Multi-omics Model for Pancreatic Cancer Screening Using cfDNA

Pancreatic Cancer Clinical Trial

Official title:

Development and Validation of Multi-omics Model for Screening of Pancreatic Cancer Using cfDNA

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456281
• Other study ID #: P04UR086-PAAD
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: Fudan University
• Contact: Xian-Jun Yu, M.D., Ph.D.
• Phone: +86-21-64175590
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: December 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Cancer Arm

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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 capture-based targeted methylation sequencing (TMS).

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Nanjing Simcere Medical Laboratory Science Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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