Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT

• Conditions: Cancer
• Interventions: Device: Multi-cancer early detection test

• Registration Number: NCT04822792
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

PRESCIENT is a multi-center, prospective observational study aimed to detect cancers early by combined assays for serum protein markers and cell-free DNA (cfDNA) methylation markers. Blood RNA markers will also be evaluated. The study will enroll approximately 11879 participants, including participants with malignancies or benign diseases, and healthy participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-23
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-03-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-29
• Last Update Posted: 2021-06-02
• Primary Completion: 2023-03-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11879

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Arm	Multi-cancer early detection test	Participants without known presence of malignancies or benign disease, from whom blood samples will be collected
Cancer Arm	Multi-cancer early detection test	Participants with new diagnosis of cancer, from whom blood samples will be collected
Benign Diseases Arm	Multi-cancer early detection test	Participants with benign diseases corresponding to the tumor types in the Cancer Arm, from whom blood samples will be collected

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of early detection of 22 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model, in combination with serum tumor markers	22 months

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with cancers or benign diseases	22 months
Sensitivity and specificity of serum tumor markers, cfDNA methylation-based model, and a cfDNA methylation-based model combined with serum tumor markers, in participants with cancers and healthy participants	22 months
Sensitivity and specificity of early detection of cancer in different stages	22 months

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China