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

Not Applicable

Recruiting

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

• Registration Number: NCT05227534
• Lead Sponsor: Guangzhou Burning Rock Dx Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Status Verified: 2022-06
• Study Start: 2022-06-01
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06
• Primary Completion: 2024-03-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)	Up to 5 years	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.
Changes in anxiety as evaluated by Self-rating Anxiety Scale (SAS) of individuals with a positive result of the multi-cancer detection test	Up to 5 years	Assessed by Self-rating Anxiety Scale (SAS). Range in score from 25 to 100 with higher scores indicate greater severity of anxiety.
Satisfaction with the multi-cancer detection test	Up to 5 years	Satisfaction will be measured by a self-reported questionnaire. Range in ranks from very satisfied, satisfied, general, unsatisfied, to very unsatisfied.
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

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China