CancerPREVENTNCT05227534
Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)
A study testing OverC multi-cancer detection blood test in people with Cancer and Early Detection of Cancer, run by Guangzhou Burning Rock Dx Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Early Detection of Cancer, Circulating Cell-free DNA
- What is being tested?
- OverC multi-cancer detection blood test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610044
Weimin Li, 18980601009, weimin003@163.com
About this study
Official title: A Prospective Multi-canceR Early-detection and interVENTional Study in Asymptomatic Individuals: PREVENT
PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.
Read the 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.
- Conditions
- Cancer, Early Detection of Cancer, Circulating Cell-free DNA
- Being tested
- OverC multi-cancer detection blood test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OverC multi-cancer detection blood testDevice
Blood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OverC multi-cancer detection blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test
Measured: 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
Measured: Up to 1 year
Secondary outcomes (4)
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.
Measured: Up to 5 years
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.
Measured: 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.
Measured: 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jun 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Burning Rock Dx Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227534
- Sponsor's protocol ID
- RSCD2022006
- Acronym
- PREVENT
- Status last verified
- Jun 2022
- First submitted
- 14 Jan 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-canceR Early-detection and interVENTional Study in Asymptomatic Individuals: PREVENT
- ClinicalTrials.gov ID
- NCT05227534
- Acronym / sponsor ID
- PREVENT / RSCD2022006
- Conditions
- Cancer, Early Detection of Cancer, Circulating Cell-free DNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12,500 participants (estimated)
- Lead sponsor
- Guangzhou Burning Rock Dx Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants 40 years of age or older with cancer risk | Experimental | Device: OverC multi-cancer detection blood testThe 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OverC multi-cancer detection blood testBlood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results | Device | Participants 40 years of age or older with cancer risk |
Primary outcome
The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test
Time frame: 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
Time frame: Up to 1 year
4 secondary outcomes
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)
Time frame: Up to 5 years
Changes in anxiety as evaluated by Self-rating Anxiety Scale (SAS) of individuals with a positive result of the multi-cancer detection test
Time frame: Up to 5 years
Satisfaction with the multi-cancer detection test
Time frame: 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
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OverC multi-cancer detection blood test in people with Cancer and Early Detection of Cancer, run by Guangzhou Burning Rock Dx Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shangli Cai (13811823843, shangli.cai@brbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.