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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer

• Study Type: Observational
• Enrollment (Estimated): 60000

Contacts and Locations

• Study Contact: Name: Wen Zou, Ph.D; Phone Number: +8615152621812; Email: zouwen@fdtzihs.org.cn
• Study Contact Backup: Name: Rui Liu, Ph.D; Email: rliu@singleragenomics.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital affiliated to Tongji Hospital, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Recruiting
      • Third Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Province Hospital
    • Taihou, Jiangsu, China, 225300
      • Recruiting
      • Fudan University Taizhou Institute of Health Sciences, Taizhou, China
      • Contact: Wen Zou, PhD
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Provincial People's Hospital
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Take physical examinations in our research centers and have no cancer history;
2. "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 ;
3. Timely feed back the information related to tumor diagnosis in other hospitals to the investigator during the program;
4. Have no birth plan for the last 3 years;
5. Fully understand the study and voluntarily sign the informed consent.

Exclusion Criteria:

1. 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;
2. Received blood transfusion, transplantation and other major operations within 3 months;
3. Participated in other interventional clinical researchs within 3 months;
4. Pregnant or lactating women;
5. Patients with autoimmune diseases, genetic diseases, mental diseases/disabilities and other diseases considered unsuitable for the study by the investigator;
6. Due to poor compliance, the researcher judged that the study could not be completed.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

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.	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

Collaborators and Investigators

• Sponsor: Singlera Genomics Inc.
• Collaborators: Fudan University
• Investigators: Study Director: Xingdong Chen, Ph.D, Fudan University Taizhou Institute of Health Sciences, Taizhou, China; Principal Investigator: Rui Liu, Ph.D, Singlera Genomics Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): July 6, 2024
• Study Completion (Estimated): December 7, 2024

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Early detection; Muti-omics; Pan-cancer screening
• Other Study ID Numbers: FuSion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No