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Multi-omics Model for Pancreatic Cancer Screening Using cfDNA | Clinical Trials | Clareo Health

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Multi-omics Model for Pancreatic Cancer Screening Using cfDNA

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

NCT06456281•Fudan University

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Cancer Arm
•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
+4 more criteria

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
+13 more criteria

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 Municipality, China

Key Dates

Start Date

June 28, 2024

Primary Completion Date

March 30, 2025

Completion Date

December 30, 2025

Last Updated

July 1, 2024

Enrollment

480

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

A noninvasive cfDNA multi-omics assay

DIAGNOSTIC_TEST

Contacts

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

CONTACT

+86-21-64175590 yuxianjun@fudanpci.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multi-omics Model for Pancreatic Cancer Screening Using cfDNA

Inclusion Criteria

Exclusion Criteria

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