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

A Prospective Multi-canceR Early-detection and interVENTional Study in Asymptomatic Individuals: PREVENT

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Early Detection of Cancer; Circulating Cell-free DNA
• Intervention / Treatment: Device: OverC multi-cancer detection blood test

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 12500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shangli Cai; Phone Number: 13811823843; Email: shangli.cai@brbiotech.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • Recruiting
      • West China Hospital, Sichuan University
      • Contact: Weimin Li; Phone Number: 18980601009; Email: weimin003@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: Participants 40 years of age or older with cancer risk; 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.	Device: OverC multi-cancer detection blood test; Blood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test	Up to 5 years
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the multi-cancer detection test alone or with standard-of-care screening as evaluated after 1-year follow-up	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in health-related quality of life in individuals with a positive result of the multi-cancer detection test assessed by Short Form Health Survey (SF-12v2)	The SF-12v2 is a measure of health related quality of life including physical component summary (PCS) and mental component summary (MCS). Both PCS and MCs have scores that range from 0 to 100. Higher values represent better health.	Up to 5 years
Changes in anxiety as evaluated by Self-rating Anxiety Scale (SAS) of individuals with a positive result of the multi-cancer detection test	Assessed by Self-rating Anxiety Scale (SAS). Range in score from 25 to 100 with higher scores indicate greater severity of anxiety.	Up to 5 years
Satisfaction with the multi-cancer detection test	Satisfaction will be measured by a self-reported questionnaire. Range in ranks from very satisfied, satisfied, general, unsatisfied, to very unsatisfied.	Up to 5 years
Sensitivity, specificity, PPV, and NPV for the multi-cancer detection blood test alone or with standard-of-care screening as evaluated after 3- and 5-year follow-up		Up to 5 years

Collaborators and Investigators

• Sponsor: Guangzhou Burning Rock Dx Co., Ltd.
• Collaborators: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: RSCD2022006

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