Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorGuangzhou Burning Rock Dx Co., Ltd.
About this trial
PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
OverC multi-cancer detection blood test
DeviceBlood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results
Treatment groups
12,500 Participants
are divided into 1 treatment groupGroup A: Participants 40 years of age or older with cancer riskExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test
Time frame
Up to 5 years2
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
Time frame
Up to 1 yearSecondary outcomes
1
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.
Time frame
Up to 5 years2
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.
Time frame
Up to 5 years3
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.
Time frame
Up to 5 years4
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
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangzhou Burning Rock Dx Co., Ltd.
Lead sponsor
West China Hospital
Collaborator
Source ClinicalTrials.gov