Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)

Burning Rock Biotech

Status: Enrolling

Conditions: Early Detection of Cancer; Circulating Cell-free DNA; Cancer

Treatments: Device: OverC multi-cancer detection blood test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05227534

RSCD2022006

Details and patient eligibility

About

PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.

Full description

Participants will receive the OverC multi-cancer detection blood test along with standard-of-care screening, whose results will be returned to health care providers and participants. The diagnostic procedures will be guided firstly by the OverC multi-cancer detection blood test and then by the standard-of-care screening. The number, cancer types, and cancer clinical stage of cancer patients diagnosed via the OverC multi-cancer detection blood test will be recorded.

The study will enroll approximately 12,500 participants as defined by eligibility criteria with an anticipated enrollment period of approximately 9 months at up to 30 clinical sites within China. Participants will be actively followed for approximately 5 years from the date of their enrollment.

Enrollment: 12,500 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be able to provide a written informed consent form
• Participants must not have received any colonoscopy, abdominal MRI/CT, low-dose CT, or chest CT within 5 years before signing the informed consent form
• Participants must be able to provide blood samples for study tests
• Participants must be between 40 and 75 years old

Exclusion criteria

• Individuals who have an acute infection or inflammation within 14 days prior to recruitment
• Individuals with cancer-associated clinical symptoms or suspected of cancer
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
• Recipient of blood transfusion within 7 days prior to recruitment
• Individuals who have pure ground-glass opacity
• Unable to provide blood samples for the multi-cancer early detection blood test
• Individuals who are unable to tolerate standard-of-care cancer screening tests or have contraindications of standard-of-care cancer screening tests
• Individuals who have taken medication with anti-tumor effects within 30 days prior to recruitment
• Individuals who have received or are undergoing curative cancer treatment within three years prior to recruitment
• Individuals with hemorrhagic diseases
• Individuals with autoimmune diseases
• Individuals who are pregnant or lactating
• Individuals who have severe comorbidities that are not suitable for participating in the trial judged by researchers

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12,500 participants in 1 patient group

Participants 40 years of age or older with cancer risk

Experimental group

Description:

The study will aim to enroll participants 40 years of age or older with cancer risk. Specific cancer risks will be enriched to increase the number of cancer events that are observed during the study.

Treatment:

Device: OverC multi-cancer detection blood test