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

NCT05159544 | Recruiting

• 1 other identifier: FuSion
• Study Type: observational
• Target: 60,000
• Locations: 1 country
• Sites: 12

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.

Conditions

Cancer

Keywords

Muti-omics; Pan-cancer screening; Early detection

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singlera Genomics Inc.: lead
• Fudan University: collaborator

Study Sites (12)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Union Hospital affiliated to Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

Fudan University Taizhou Institute of Health Sciences, Taizhou, China

Taihou, Jiangsu, 225300, China

RECRUITING

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 32694610 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Xingdong Chen, Ph.D

  Fudan University Taizhou Institute of Health Sciences, Taizhou, China

  STUDY DIRECTOR

• Rui Liu, Ph.D

  Singlera Genomics Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Zou, Ph.D

CONTACT

+8615152621812; zouwen@fdtzihs.org.cn

Rui Liu, Ph.D

CONTACT

rliu@singleragenomics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 16, 2021
• Study Start: July 6, 2021
• Primary Completion: July 6, 2024
• Study Completion: December 7, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)