The FuSion Program: A Prospective and Multicenter Cohort Study of Pan-Cancer Screening in Chinese Population

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Prospective, Multicenter, Noninterventional Cohort Study of Muti-Omics Models for Pan-Cancer Screening

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Take physical examinations in our research centers and have no cancer history; Population Health tracking Survey - simplified version of the questionnaire must be filled according to the research program and an annual physical examination can be received as follow-up ; Timely feed back the information related to tumor diagnosis in other hospitals to the investigator during the program; Have no birth plan for the last 3 years; Fully understand the study and voluntarily sign the informed consent. Exclusion Criteria: Have been diagnosed with esophageal cancer, gastric cancer, colorectal cancer, liver cancer, lung cancer, pancreatic cancer, breast cancer (including non-primary, such as recurrence, metastasis or other complications) and other malignant tumors; Received blood transfusion, transplantation and other major operations within 3 months; Participated in other interventional clinical researchs within 3 months; Pregnant or lactating women; Patients with autoimmune diseases, genetic diseases, mental diseases/disabilities and other diseases considered unsuitable for the study by the investigator; Due to poor compliance, the researcher judged that the study could not be completed.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multi-omics model developing and training arm<br>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<br>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<br>Participants in Taizhou cohort will be selected. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. |  | assessed up to 36 months | 
| To evaluate sensitivity,specificity,positive/negative predictive value of the screening model in participants taking routine annual physicals |  | assessed up to 24 months | 
| To validate model's efficacy and clinical value in the diagnosis of cancers in Taizhou cohort. |  | assessed up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muti-omics, Pan-cancer screening, Early detection