Actively Recruiting
A Prospective Multi-canceR Early-detection and interVENTional Study in Asymptomatic Individuals: PREVENT
Led by Guangzhou Burning Rock Dx Co., Ltd. · Updated on 2022-07-06
12500
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
G
Guangzhou Burning Rock Dx Co., Ltd.
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of the OverC multi-cancer detection blood test in people aged 40 to 75 who are at risk for cancer but do not show symptoms. This prospective, multicenter, interventional study aims to understand how well this blood test detects various cancers early and records details like cancer types and stages when diagnosed. The study is sponsored by Guangzhou Burning Rock Dx Co., Ltd. and will take place at up to 30 clinical sites within China. Participants will receive the OverC multi-cancer detection blood test alongside standard cancer screening tests. The results from both tests will be shared with health care providers and participants. Diagnostic procedures will first be guided by the blood test results, followed by standard screening methods. The study plans to enroll about 12,500 participants over approximately 9 months, focusing on those with specific cancer risks to increase observed cancer cases. Participants will be actively followed for about 5 years after enrollment. Researchers will collect blood samples, track cancer diagnoses, and evaluate the effectiveness of the blood test by measuring sensitivity, specificity, and predictive values at 1, 3, and 5 years. They will also assess participants' quality of life, anxiety levels, and satisfaction with the test during this time. Safety and disease progression will be monitored throughout the study period.
CONDITIONS
Brief Title
Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 years
Participants receive the OverC multi-cancer detection blood test along with standard-of-care cancer screening. Results are returned to health care providers and participants, guiding any further diagnostic procedures.
Periodic blood tests and standard-of-care screenings as per study schedule
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
Research Team
S
Shangli Cai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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