CancerNCT05159544
The FuSion Program: A Prospective and Multicenter Cohort Study of Pan-Cancer Screening in Chinese Population
An observational study of Cancer, run by Singlera Genomics Inc. at 12 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 60,000 participants
- Where
- 12 sitesChina
- Study dates
- 6 Jul 2021to 7 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
Rui Liu, Ph.D contact
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality
- Recruiting
Third Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
- Recruiting
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
- Recruiting
Fudan University Taizhou Institute of Health Sciences, Taizhou, China
Taihou, Jiangsu, 225300
Wen Zou, PhD
- Recruiting
Union Hospital affiliated to Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: 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.
- Conditions
- Cancer
- Keywords
- Muti-omics, Pan-cancer screening, Early detection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start6 Jul 2021
- Primary completion6 Jul 2024 (estimated)
- Study completion7 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singlera Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Xingdong Chen, Ph.D, Study director, Fudan University Taizhou Institute of Health Sciences, Taizhou, ChinaRui Liu, Ph.D, Principal investigator, Singlera Genomics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159544
- Sponsor's protocol ID
- FuSion
- Status last verified
- Apr 2024
- First submitted
- 2 Dec 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32694610
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Noninterventional Cohort Study of Muti-Omics Models for Pan-Cancer Screening
- ClinicalTrials.gov ID
- NCT05159544
- Acronym / sponsor ID
- FuSion
- Conditions
- Cancer
- Keywords
- Muti-omics, Pan-cancer screening, Early detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Singlera Genomics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 6 Jul 2024 (estimated)
- Study completion
- 7 Dec 2024 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 32694610Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Liu, Ph.D contact
Xingdong Chen, Ph.D study director
Fudan University Taizhou Institute of Health Sciences, Taizhou, China
Rui Liu, Ph.D principal investigator
Singlera Genomics Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Singlera Genomics Inc. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Zou, Ph.D (+8615152621812, zouwen@fdtzihs.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05159544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.