NCT06790355

ProSight: a Multi-centre Interventional Study Evaluating MCED in Asymptomatic Population

Feasibility of Blood-based Test for Multi-cancer Early Detection in Asymptomatic Screening Population（ProSight）: a Multi-centre Interventional Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,527 (estimated)
• Sponsor: Shanghai Weihe Medical Laboratory Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.

Detailed description

Approximately 2527 participants will be enrolled and offered the multi-cancer early detection (MCED) test along with standard-of-care (SOC) cancer screenings and usual medical care. The investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. The test provides a binary result and predicts the signal origins if a cancer signal is detected. Those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. The diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol. Both the safety and performance of MCED in the screening setting will be evaluated. The extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. Additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the Electronic Clinical Outcome Assessment (eCOA) app. Participants will be actively followed for 1 year from the date of the blood draw.

Conditions

• Lung Cancer
• Colorectal Cancer
• Liver Cancer
• Grastic Cancer
• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	multi-cancer early detection	Blood collection for multi-cancer early detection（MCED）, followed by clinical diagnosis based on the results of MCED and standard-of-care screening

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-01-24
• Last updated: 2025-01-24