Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study

Changhai Hospital1 site in 1 country450 target enrollmentMarch 24, 2022

ConditionsCancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: Changhai Hospital
Enrollment: 450
Locations: 1
Primary Endpoint: The sensitivity and specificity of multi-cancer early detection by the combined model in cancer arm and benign disease arm
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

DAYBREAK is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, serum protein markers, blood miRNA markers and others, in which of 450 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers and benign disease through a two-stage approach. The sensitivity and specificity of the model in pancreatic cancer early detection will be evaluated.

Registry

clinicaltrials.gov

Start Date

March 24, 2022

End Date

June 30, 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Changhai Hospital

Responsible Party

Principal Investigator

Guo ShiWei

Associated Professor at the Institute of Pancreatic Surgery

Changhai Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

The sensitivity and specificity of multi-cancer early detection by the combined model in cancer arm and benign disease arm

Time Frame: 12 months

Secondary Outcomes

The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages.(12 months)
Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers.(12 months)
Sensitivity and specificity for detecting pancreatic cancer of a the protein panel-based model, in combination with other biomarkers.(12 months)
Sensitivity and specificity of the blood miRNA-based model in detecting pancreatic cancer.(12 months)