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

N/ANot Yet RecruitingNCT06790355

Shanghai Weihe Medical Laboratory Co., Ltd.2,527 enrolled

Overview

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

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

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

2,527

Conditions

Lung Cancer Colorectal Cancer Liver Cancer Grastic Cancer Esophageal Cancer

Interventions

multi-cancer early detectionDEVICE

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.