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

September 1, 2026 updated by: Shanghai Weihe Medical Laboratory Co., Ltd.

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

2527

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: From enrollment to the Follow-up at 1 year
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.
Time Frame: From enrollment to the Follow-up at 1 year
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.
Time Frame: From enrollment to the Follow-up at 1 year
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.
Time Frame: From enrollment to the Follow-up at 1 year
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.
Time Frame: From enrollment to the Follow-up at 1 year
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.
Time Frame: From enrollment to the Follow-up at 1 year
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) .
Time Frame: From enrollment to the Follow-up at 1 year
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.
Time Frame: From enrollment to the Follow-up at 1 year
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.
Time Frame: From enrollment to the Follow-up at 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Weihe Medical Laboratory Co., Ltd.

Collaborators

Fudan University

Investigators

  • Principal Investigator: Xianjun Yu, Fudan University
  • Study Director: Xiaohui Wu, Shanghai Weihe Medical Laboratory Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

August 31, 2026

Study Completion (Actual)

August 31, 2026

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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