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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants 40 years of age or older with cancer risk | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OverC multi-cancer detection blood test | Device | Blood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results |
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| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shangli Cai | Contact | 13811823843 | shangli.cai@brbiotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610044 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 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 |