Pan-canceR Early DetectIon projeCT

• Conditions: Cancer

• Registration Number: NCT04383353
• Lead Sponsor: Guangzhou Burning Rock Dx Co., Ltd.

Brief Summary

PREDICT is a prospective, multi-center 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 early stage 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

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Study Start: 2020-07-21
• Last Update Posted: 2020-07-22
• Primary Completion: 2022-10
• Study Completion: 2023-03

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

Primary Outcome Measures

Name	Time	Method
The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.	32 months
The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model.	32 months

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups.	32 months
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in combination with clinicopathological characteristics or other biomarkers.	32 months
The examinations related to cancer diagnosis from the participants who were identified as positive cases by cfDNA methylation based model while as healthy individuals by routine medical examinations.	32 months
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in the independent training and validation sets.	32 months

Trial Locations

Locations (3)

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

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

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