a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）

Recruiting

• Conditions: Cancer

• Registration Number: NCT06217900
• Lead Sponsor: Shanghai Weihe Medical Laboratory Co., Ltd.

Brief Summary

This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.

Detailed Description

Blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis will be prospectively collected to identify cancer-specific circulating signals through integrative multi-omic analysis. Based on the comprehensive molecular profiling, a machine learning-driven model will be trained and blinded validated independent through a two-stage approach in clinically annotated individuals. Approximately 10327 cancer patients will be enrolled in this study and early-stage cancer patients will be enriched to improve the model sensitivity on distinguishing cancers with favorable prognosis. Approximately 6339 age and sex matched controls will be included in model development, which are volunteers without a cancer diagnosis after routine cancer screening tests.

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-28
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2026-10-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16666

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The performance of cfDNA methylation-based multiple cancers early detection model in case-control study	12 months	The sensitivity, specificity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
The performance of cfDNA methylation-based multiple cancers early detection model in early stage cancer cases	12 months	The sensitivity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting stage I to II cancer at 95% confidence interval.
The performance of multi-omic-based multiple cancers early detection model in case-control study	12 months	The sensitivity, specificity and tissue origin accuracy of multi-omic-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.
The performance of different multi-cancer early detection models in different subgroups	12 months	The sensitivity and specificity of cfDNA methylation-based or multi-omic-based multiple cancers early detection model in different subgroups of the population (such as age, gender, cancer pathological classification, and clinical stage) at 95% confidence interval.

Trial Locations

Locations (2)

Peking University Cancer Hospital and Institute; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China