Pan-canceR Early DetectIon projeCT (PREDICT)

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

• Registration Number: NCT04817306
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

PREDICT is a prospective, multicenter study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation-based model, in which approximately 14,000 participants will be enrolled. The development and validation of the model will be conducted in participants with cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach. The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-26
• Study Start: 2021-03-29
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14026

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
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
Cancer Arm	Multi-cancer early detection test	Participants with new diagnosis of cancer, from whom blood samples will be collected
Non-tumor (Healthy) Arm	Multi-cancer early detection test	Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of early detection of cancer and TOO accuracy of a cfDNA methylation-based model	24 months
Sensitivity of early detection of cancer and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model when specificity is 90%, 95% or 98% in healthy participants	24 months

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages of cancer	24 months
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in various types of cancer	24 months
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model, in combination with clinical characteristics and other biomarkers	24 months

Trial Locations

Locations (3)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Ninth People's Hospital, Shanghai JiaoTong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China

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