A program for early cancer detection in the Chinese population

A Prospective, Multicenter, Noninterventional Cohort Study of Muti-Omics Models for Pan-Cancer Screening

This study is testing a new screening program for early cancer detection in 50,000 people in China to see how well it works.

Quick facts

• Study type: Observational
• Enrollment: 60000 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Singlera Genomics Inc. (industry)
• Locations: 12 sites (Hefei, Anhui and 11 other locations)
• Trial ID: NCT05159544 on ClinicalTrials.gov

What this trial studies

The FuSion Program is an observational study aimed at evaluating a multi-omics model for pan-cancer screening in a cohort of 50,000 individuals over three years. This study will assess the sensitivity, specificity, and predictive values of the screening model developed by Fudan University and Singlera. Participants will undergo routine annual physicals and provide genetic information, epidemiological risk factors, and tumor markers to optimize the screening model. The effectiveness of this model will be validated in a real-world cohort in Taizhou.

Who should consider this trial

Good fit: Ideal candidates are individuals undergoing routine physical examinations with no prior history of cancer.

Not a fit: Patients with a history of specific cancers or those who have undergone major surgeries recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve early cancer detection rates in the Chinese population.

How similar studies have performed: Other studies have shown promise in multi-omics approaches for cancer detection, suggesting potential success for this novel initiative.

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.

Where this trial is running

Hefei, Anhui and 11 other locations

• The First Affiliated Hospital of USTC (Anhui Provincial Hospital) — Hefei, Anhui, China (RECRUITING)
• Beijing Hospital — Beijing, Beijing, China (RECRUITING)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing, 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, China (RECRUITING)
• Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (RECRUITING)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Rui Liu, Ph.D — Singlera Genomics Inc.
• Study coordinator: Wen Zou, Ph.D

Conditions: Cancer, Muti-omics, Pan-cancer screening, Early detection