Developing a platform for early cancer detection using DNA analysis
A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers.
This study is testing a new way to detect cancer early by analyzing DNA from blood samples of both cancer patients and healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06231953 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a Multi-Cancer Early Detection (MCED) platform by analyzing whole genome sequencing of circulating tumor DNA from both cancer patients and healthy volunteers. The study will enroll 4,000 participants across multiple clinical institutions in South Korea. Blood samples will be collected from individuals diagnosed with invasive cancers and healthy volunteers undergoing cancer screening. The data will be processed using machine learning techniques to enhance early cancer detection capabilities.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 19 years or older diagnosed with stages 1 to 4 of solid tumors or healthy volunteers scheduled for cancer screening.
Not a fit: Patients with a history of certain infections, severe mental disorders, or multiple primary cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve early cancer detection, leading to better treatment outcomes for patients.
How similar studies have performed: Other studies utilizing similar approaches in early cancer detection have shown promising results, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 19 years or older * Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination * Subjects who have agreed to provide clinical information and blood samples * Subjects who have agreed for the storage and secondary use of residual blood samples for research * Subjects who have understood the study and are able to provide a written informed consent Exclusion Criteria: * Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders * Subjects with a history of HIV, HTLV, or Syphilis infection * Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers * Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)
Where this trial is running
Seoul
- Yonsei Cancer Center, Yonsei Univ. College of Medicine — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Joohyuk Sohn — Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
- Study coordinator: Joohyuk Sohn
- Email: oncosohn@yuhs.ac
- Phone: +82-2-2228-8135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.