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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05159544
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : April 17, 2024
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Singlera Genomics Inc.

Study Description
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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.

Condition or disease
Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 60000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Noninterventional Cohort Study of Muti-Omics Models for Pan-Cancer Screening
Actual Study Start Date : July 6, 2021
Estimated Primary Completion Date : July 6, 2024
Estimated Study Completion Date : December 7, 2024
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05159544


Contacts
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Contact: Wen Zou, Ph.D +8615152621812 zouwen@fdtzihs.org.cn
Contact: Rui Liu, Ph.D rliu@singleragenomics.com

Locations
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China, Anhui
The First Affiliated Hospital of USTC (Anhui Provincial Hospital) Recruiting
Hefei, Anhui, China
China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China
China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China
China, Hubei
Union Hospital affiliated to Tongji Hospital, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
China, Hunan
Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China
Fudan University Taizhou Institute of Health Sciences, Taizhou, China Recruiting
Taihou, Jiangsu, China, 225300
Contact: Wen Zou, PhD         
China, Shanghai
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China
China, Sichuan
Sichuan Provincial People's Hospital Recruiting
Chengdu, Sichuan, China
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China
Sponsors and Collaborators
Singlera Genomics Inc.
Fudan University
Investigators
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Study Director: Xingdong Chen, Ph.D Fudan University Taizhou Institute of Health Sciences, Taizhou, China
Principal Investigator: Rui Liu, Ph.D Singlera Genomics Inc.
More Information
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Publications:

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Responsible Party: Singlera Genomics Inc.
ClinicalTrials.gov Identifier: NCT05159544    
Other Study ID Numbers: FuSion
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singlera Genomics Inc.:
Muti-omics
Pan-cancer screening
Early detection