Cancer, Circulating Cell-free DNA, Early Detection of Cancer
Conditions
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.
Interventions
DEVICEOverC multi-cancer detection blood test
Blood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results
Sponsors
West China Hospital
Guangzhou Burning Rock Dx Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactShangli Cai
Outcome results
None listed