Lung CancerNCT06790355
ProSight: A Multi-centre Interventional Study Evaluating MCED in Asymptomatic Population
A study testing multi-cancer early detection in people with Lung Cancer and Colorectal Cancer, run by Shanghai Weihe Medical Laboratory Co., Ltd. at 4 sites in China.
Trial summary
This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Colorectal Cancer, Liver Cancer
- What is being tested?
- multi-cancer early detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,527 participants
- Where
- 4 sitesChina
- Study dates
- 1 Mar 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-74 years old
- Able to provide a written informed consent and willing to comply with all parts of the protocol procedures
Who cannot join
- With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen
- Have definite contraindications of cancer screening examination and diagnostic procedures
- Unable to comply with the protocol procedures
- Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date
- Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion.
- Recipients of anti-tumor therapy within 30 days prior to screen
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- Pregnancy or lactating women
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 7 days prior to screen
- With autoimmune diseases
- Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw
- Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)
Trial locations and contacts
4 sites in 1 country.
China4 sites
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: Feasibility of Blood-based Test for Multi-cancer Early Detection in Asymptomatic Screening Population（ProSight）: a Multi-centre Interventional Study
This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.
Read the detailed description
Approximately 2527 participants will be enrolled and offered the multi-cancer early detection (MCED) test along with standard-of-care (SOC) cancer screenings and usual medical care. The investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. The test provides a binary result and predicts the signal origins if a cancer signal is detected. Those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. The diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol.
Both the safety and performance of MCED in the screening setting will be evaluated. The extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. Additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the Electronic Clinical Outcome Assessment (eCOA) app.
Participants will be actively followed for 1 year from the date of the blood draw.
- Conditions
- Lung Cancer, Colorectal Cancer, Liver Cancer, Grastic Cancer, Esophageal Cancer
- Being tested
- multi-cancer early detection
- Keywords
- multi-cancer early detection, MCED, cancer screening, circulating cell-free tumor DNA, methylation
- Medical subject headings
- Lung Neoplasms, Colorectal Neoplasms, Liver Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-cancer early detectionDevice
Blood collection for multi-cancer early detection（MCED）, followed by clinical diagnosis based on the results of MCED and standard-of-care screening
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Not described Receives: Device: multi-cancer early detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MCED in the intended use setting.
Descriptive statistics will be used to summarize the number of 5 pre-specified cancers diagnosed by MCED.
Measured: From enrollment to the Follow-up at 1 year
Safety of MCED in the intended use setting.
Descriptive statistics will be used to summarize the time to achieve diagnostic resolution following receipt of a positive MCED test and to assess the extent of testing pursued.
Measured: From enrollment to the Follow-up at 1 year
Secondary outcomes (5)
Performance of MCED in the intended use setting.
Positive Predictive Value defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" test result.
Measured: From enrollment to the Follow-up at 1 year
Cancer signal origin accuracy of MCED.
Cancer signal origin accuracy defined as the proportion of participants with correct SCO predictions among those with positive test results who had a cancer diagnosis.
Measured: From enrollment to the Follow-up at 1 year
Clinical utility of MCED alongside SOC screening.
Descriptive statistics will be used to summarize the number and types of cancers diagnosed by MCED among participants who are ineligible for SOC screening.
Measured: From enrollment to the Follow-up at 1 year
Participant-reported psychological impact.
Changes in anxiety during study will be assessed using the short form of STAI (The state-trait anxiety inventory). Descriptive statistics for a total score will be used to measure feelings of anxiety.
Measured: From enrollment to the Follow-up at 1 year
Participant-reported health related quality of life (HRQoL) .
Changes in HRQoL during study will be assessed using the EQ-5D-5L. Descriptive statistics for an index value at various time points will be used to reflect how good or bad a health state is.
Measured: From enrollment to the Follow-up at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Mar 2025
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- 2,527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Xianjun Yu, Principal investigator, Fudan UniversityXiaohui Wu, Study director, Shanghai Weihe Medical Laboratory Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790355
- Sponsor's protocol ID
- Genie-ProSight
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Blood-based Test for Multi-cancer Early Detection in Asymptomatic Screening Population（ProSight）: a Multi-centre Interventional Study
- ClinicalTrials.gov ID
- NCT06790355
- Acronym / sponsor ID
- Genie-ProSight
- Conditions
- Lung Cancer, Colorectal Cancer, Liver Cancer, Grastic Cancer, Esophageal Cancer
- Keywords
- multi-cancer early detection, MCED, cancer screening, circulating cell-free tumor DNA, methylation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,527 participants (actual)
- Lead sponsor
- Shanghai Weihe Medical Laboratory Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 24 Jan 2025 (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.
This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.
Detailed description
Approximately 2527 participants will be enrolled and offered the multi-cancer early detection (MCED) test along with standard-of-care (SOC) cancer screenings and usual medical care. The investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. The test provides a binary result and predicts the signal origins if a cancer signal is detected. Those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. The diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol.
Both the safety and performance of MCED in the screening setting will be evaluated. The extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. Additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the Electronic Clinical Outcome Assessment (eCOA) app.
Participants will be actively followed for 1 year from the date of the blood draw.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: multi-cancer early detection |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40-74 years old
- Able to provide a written informed consent and willing to comply with all parts of the protocol procedures
Key exclusion criteria (12 listed)
- With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen
- Have definite contraindications of cancer screening examination and diagnostic procedures
- Unable to comply with the protocol procedures
- Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date
- Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion.
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 |
|---|---|---|
| multi-cancer early detectionBlood collection for multi-cancer early detection（MCED）, followed by clinical diagnosis based on the results of MCED and standard-of-care screening | Device | Healthy subjects |
Primary outcome
Feasibility of MCED in the intended use setting.
Time frame: From enrollment to the Follow-up at 1 year
Descriptive statistics will be used to summarize the number of 5 pre-specified cancers diagnosed by MCED.
Safety of MCED in the intended use setting.
Time frame: From enrollment to the Follow-up at 1 year
Descriptive statistics will be used to summarize the time to achieve diagnostic resolution following receipt of a positive MCED test and to assess the extent of testing pursued.
5 secondary outcomes
Performance of MCED in the intended use setting.
Time frame: From enrollment to the Follow-up at 1 year
Cancer signal origin accuracy of MCED.
Time frame: From enrollment to the Follow-up at 1 year
Clinical utility of MCED alongside SOC screening.
Time frame: From enrollment to the Follow-up at 1 year
Participant-reported psychological impact.
Time frame: From enrollment to the Follow-up at 1 year
Participant-reported health related quality of life (HRQoL) .
Time frame: From enrollment to the Follow-up at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- 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. This study is not recruiting at the moment.
Xianjun Yu principal investigator
Fudan University
Xiaohui Wu study director
Shanghai Weihe Medical Laboratory Co., Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-cancer early detection in people with Lung Cancer and Colorectal Cancer, run by Shanghai Weihe Medical Laboratory Co., Ltd. at 4 sites 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of MCED in the intended use setting. (time frame: From enrollment to the Follow-up at 1 year). 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 4 Sep 2026.