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

NCT ID: NCT05159544

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-06

Study Completion Date

2024-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Multi-omics model evaluating arm

Participants in Taizhou cohort will be selected.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fudan University

OTHER

Sponsor Role collaborator

Singlera Genomics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xingdong Chen, Ph.D

Role: STUDY_DIRECTOR

Fudan University Taizhou Institute of Health Sciences, Taizhou, China

Rui Liu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Singlera Genomics Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

Site Status RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

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

Wuhan, Hubei, China

Site Status RECRUITING

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Fudan University Taizhou Institute of Health Sciences, Taizhou, China

Taihou, Jiangsu, China

Site Status RECRUITING

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wen Zou, Ph.D

Role: CONTACT

+8615152621812

Rui Liu, Ph.D

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wen Zou, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32694610 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FuSion

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.