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

• ClinicalTrials.gov Identifier: NCT05159544
• Recruitment Status: Recruiting
• First Posted: December 16, 2021
• Last Update Posted: April 17, 2024
• Sponsor: Singlera Genomics Inc.
• Collaborator: Fudan University
• Information provided by (Responsible Party): Singlera Genomics Inc.

Tracking Information

• First Submitted Date: December 2, 2021
• First Posted Date: December 16, 2021
• Last Update Posted Date: April 17, 2024
• Actual Study Start Date: July 6, 2021
• Estimated Primary Completion Date: July 6, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 15, 2024)

• To develop a multi-omics model for pan-cancer screening integrating the markers of ctDNA mutation, DNA fragmentation and methylation et al. [ Time Frame: assessed up to 36 months ]
  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.
• To evaluate sensitivity,specificity,positive/negative predictive value of the screening model in participants taking routine annual physicals [ Time Frame: assessed up to 24 months ]
  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.
• To validate model's efficacy and clinical value in the diagnosis of cancers in Taizhou cohort. [ Time Frame: assessed up to 12 months ]
  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.

Original Primary Outcome Measures (submitted: December 2, 2021)

• To develop a multi-omics model for pan-cancer screening integrating the markers of ctDNA mutation, DNA fragmentation and methylation et al. [ Time Frame: assessed up to 36 months ]
• To evaluate sensitivity,specificity,positive/negative predictive value of the screening model in participants taking routine annual physicals [ Time Frame: assessed up to 24 months ]
• To validate model's efficacy and clinical value in the diagnosis of cancers in Taizhou cohort. [ Time Frame: assessed up to 12 months ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The FuSion Program: A Prospective and Multicenter Cohort Study of Pan-Cancer Screening in Chinese Population
• Official Title: A Prospective, Multicenter, Noninterventional Cohort Study of Muti-Omics Models for Pan-Cancer Screening
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Cancer
• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 2, 2021): 60000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 7, 2024
• Estimated Primary Completion Date: July 6, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Wen Zou, Ph.D; +8615152621812; zouwen@fdtzihs.org.cn

Contact: Rui Liu, Ph.D; rliu@singleragenomics.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05159544
• Other Study ID Numbers: FuSion
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Singlera Genomics Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Singlera Genomics Inc.
• Original Study Sponsor: Same as current
• 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.

• PRS Account: Singlera Genomics Inc.
• Verification Date: April 2024