Clinical trial NCT05227534: Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)
Official title: A Prospective Multi-canceR Early-detection and interVENTional Study in Asymptomatic Individuals: PREVENT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Early Detection of Cancer
Circulating Cell-free DNA
Lead sponsor: Guangzhou Burning Rock Dx Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: West China Hospital
First posted: 2022-02-07
Enrollment: 12500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test
timeFrame: Up to 5 years
measure: 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
timeFrame: Up to 1 year
Secondary outcomes:
measure: 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)
timeFrame: Up to 5 years
measure: Changes in anxiety as evaluated by Self-rating Anxiety Scale (SAS) of individuals with a positive result of the multi-cancer detection test
timeFrame: Up to 5 years
measure: Satisfaction with the multi-cancer detection test
timeFrame: Up to 5 years
measure: 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
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: