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

Cancer Clinical Trial

— PREVENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227534
• Other study ID #: RSCD2022006
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2022
• Source: Guangzhou Burning Rock Dx Co., Ltd.
• Contact: Shangli Cai
• Phone: 13811823843
• Email: shangli.cai[@]brbiotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12500
• Est. completion date: December 31, 2028
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Early Detection of Cancer

Intervention

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

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Burning Rock Dx Co., Ltd.	West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test		Up to 5 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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