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| Name | Class |
|---|---|
| Fudan University | OTHER |
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This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-cancer early detection | Device | Blood collection for multi-cancer early detection(MCED), followed by clinical diagnosis based on the results of MCED and standard-of-care screening |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment to the Follow-up at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the Follow-up at 1 year |
| Cancer signal origin accuracy of MCED. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant-reported satisfaction with MCED. | Descriptive statistics for a total score across all questions and individual ratings for each question. | From enrollment to the Follow-up at 1 year |
| Cross-reactivity of MCED. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Qin | Contact | 0086-15827587695 | qindan.556@bytedance.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianjun Yu | Fudan University | Principal Investigator |
| Xiaohui Wu | Shanghai Weihe Medical Laboratory Co., Ltd. | Study Director |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008113 | Liver Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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. |
| 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. | 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. | 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. | From enrollment to the Follow-up at 1 year |
Descriptive statistics will be used to summarize the number and types of untrained cancers (beyond the 5 pre-specified cancers) diagnosed by MCED in participants for whom cancer signal origin directed workups do not result in diagnosis of cancer.
| From enrollment to the Follow-up at 1 year |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008107 | Liver Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |