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

NCT ID: NCT06790355

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2527 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Healthy subjects

Group Type: EXPERIMENTAL

multi-cancer early detection

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 40-74 years old
• Able to provide a written informed consent and willing to comply with all parts of the protocol procedures

Exclusion Criteria

• With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen
• Have definite contraindications of cancer screening examination and diagnostic procedures
• Unable to comply with the protocol procedures
• Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date
• Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion.
• Recipients of anti-tumor therapy within 30 days prior to screen
• Pregnancy or lactating women
• Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 7 days prior to screen
• With autoimmune diseases
• Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw
• Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai Weihe Medical Laboratory Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xianjun Yu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Xiaohui Wu

Role: STUDY_DIRECTOR

Shanghai Weihe Medical Laboratory Co., Ltd.

Central Contacts

Dan Qin

Role: CONTACT

qindan.556@bytedance.com

0086-15827587695

Other Identifiers

Genie-ProSight

Identifier Type: -

Identifier Source: org_study_id