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| Name | Class |
|---|---|
| Fudan University | OTHER |
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The integrative study by Fudan and Singlera for cancer early detection(The FuSion Program ) will evaluate sensitivity,specificity and positive/negative predictive value of the screening model jointly developed by FuDan University and Singlera in a 2-year follow-up corhort including 10,000 persons in routine annual physicals from dozens of hospitals. The multi-omics model for pan-cancer screening will be developed in a 3-year follow-up corhort including 50,000 natural persons in community containing genetic information of tumor families, assessment of epidemiological risk factors, tumor markers, proteomics, genomics and DNA methylation. After optimizing, the ability of this model will be validated in the Taizhou corhort in reality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-omics model developing and training arm | Blood samples and individual health information from 50,000 participants in community, who got 3-year follow-up are selected. | ||
| Multi-omics model validating arm | 10,000 participants in routine annual physicals from hospitals will be selected, and they will be followed up for 2 years. | ||
| Multi-omics model evaluating arm | Participants in Taizhou cohort will be selected. |
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| Measure | Description | Time Frame |
|---|---|---|
| To develop a multi-omics model for pan-cancer screening integrating the markers of ctDNA mutation, DNA fragmentation and methylation et al. | To construct a multi-dimensional ensembled stacked machine learning approach, employing several different base models on ctDNA mutation, DNA fragmentation and mehylation, to provide an effective model for cancer early detection. | assessed up to 36 months |
| To evaluate sensitivity,specificity,positive/negative predictive value of the screening model in participants taking routine annual physicals | Sensitivity: the ability of a test to correctly identify patients with a disease. Specificity: the ability of a test to correctly identify people without the disease. Positive predictive value refers to the probability of the person having the disease when the test is positive. Negative predictive value refers to the probability of the person not having the disease when the test is negative. | assessed up to 24 months |
| To validate model's efficacy and clinical value in the diagnosis of cancers in Taizhou cohort. | Cancer early detection could increase detection of cancer at early stages, when survival outcomes are better and treatment costs are lower. we will explore whether this model with high specificity could potentially improve long-term health outcomes and reduce cancer treatment costs. | assessed up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible participants will be recruited from the communities in Taizhou city and medical centers in different provinces, including normal healthy people, high-risk people, those with benign disease and malignant diseases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Zou, Ph.D | Contact | +8615152621812 | zouwen@fdtzihs.org.cn | |
| Rui Liu, Ph.D | Contact | rliu@singleragenomics.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingdong Chen, Ph.D | Fudan University Taizhou Institute of Health Sciences, Taizhou, China | Study Director |
| Rui Liu, Ph.D | Singlera Genomics Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Recruiting | Hefei | Anhui | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32694610 | Background | Chen X, Gole J, Gore A, He Q, Lu M, Min J, Yuan Z, Yang X, Jiang Y, Zhang T, Suo C, Li X, Cheng L, Zhang Z, Niu H, Li Z, Xie Z, Shi H, Zhang X, Fan M, Wang X, Yang Y, Dang J, McConnell C, Zhang J, Wang J, Yu S, Ye W, Gao Y, Zhang K, Liu R, Jin L. Non-invasive early detection of cancer four years before conventional diagnosis using a blood test. Nat Commun. 2020 Jul 21;11(1):3475. doi: 10.1038/s41467-020-17316-z. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Beijing Hospital |
| Recruiting |
| Beijing |
| Beijing Municipality |
| China |
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
| Union Hospital affiliated to Tongji Hospital, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
| Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
| Fudan University Taizhou Institute of Health Sciences, Taizhou, China | Recruiting | Taihou | Jiangsu | 225300 | China |
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| Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |