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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Esophageal Cancer; Lung Cancer; Liver Cancer; Grastic Cancer
• Intervention / Treatment: Device: multi-cancer early detection

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.

• Study Type: Interventional
• Enrollment (Estimated): 2527
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Qin; Phone Number: 0086-15827587695; Email: qindan.556@bytedance.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subjects	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of MCED in the intended use setting.	Descriptive statistics will be used to summarize the number of 5 pre-specified cancers diagnosed by MCED.	From enrollment to the Follow-up at 1 year
Safety of MCED in the intended use setting.	Descriptive statistics will be used to summarize the time to achieve diagnostic resolution following receipt of a positive MCED test and to assess the extent of testing pursued.	From enrollment to the Follow-up at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of MCED in the intended use setting.	Positive Predictive Value defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" test result.	From enrollment to the Follow-up at 1 year
Cancer signal origin accuracy of MCED.	Cancer signal origin accuracy defined as the proportion of participants with correct SCO predictions among those with positive test results who had a cancer diagnosis.	From enrollment to the Follow-up at 1 year
Clinical utility of MCED alongside SOC screening.	Descriptive statistics will be used to summarize the number and types of cancers diagnosed by MCED among participants who are ineligible for SOC screening.	From enrollment to the Follow-up at 1 year
Participant-reported psychological impact.	Changes in anxiety during study will be assessed using the short form of STAI (The state-trait anxiety inventory). Descriptive statistics for a total score will be used to measure feelings of anxiety.	From enrollment to the Follow-up at 1 year
Participant-reported health related quality of life (HRQoL) .	Changes in HRQoL during study will be assessed using the EQ-5D-5L. Descriptive statistics for an index value at various time points will be used to reflect how good or bad a health state is.	From enrollment to the Follow-up at 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-reported satisfaction with MCED.	Descriptive statistics for a total score across all questions and individual ratings for each question.	From enrollment to the Follow-up at 1 year
Cross-reactivity of MCED.	Descriptive statistics will be used to summarize the number and types of untrained cancers (beyond the 5 pre-specified cancers) diagnosed by MCED in participants for whom cancer signal origin directed workups do not result in diagnosis of cancer.	From enrollment to the Follow-up at 1 year

Collaborators and Investigators

• Sponsor: Shanghai Weihe Medical Laboratory Co., Ltd.
• Collaborators: Fudan University Shanghai Cancer Center ( FUSCC )
• Investigators: Study Director: Xiaohui Wu, Shanghai Weihe Medical Laboratory Co., Ltd.; Principal Investigator: Xianjun Yu, Fudan University Shanghai Cancer Center ( FUSCC )

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: cancer screening; multi-cancer early detection; circulating cell-free tumor DNA; MCED; methylation
• Other Study ID Numbers: Genie-ProSight

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No