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

Shanghai Weihe Medical Laboratory

Status

Not yet enrolling

Conditions

Esophageal Cancer

Grastic Cancer

Lung Cancer

Liver Cancer

Colorectal Cancer

Treatments

Device: multi-cancer early detection

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06790355

Genie-ProSight

Details and patient eligibility

About

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

Full 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.

Enrollment

2,527 estimated patients

Sex

All

Ages

40 to 74 years old

Volunteers

Accepts Healthy Volunteers

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)