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This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA.
The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.
AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer.
The purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers.
The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer patients | Patients who have diagnosed as invasive cancers | ||
| Healthy volunteers | Subjects who have done cancer screening tests |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value | 36 months | |
| Accuracy of prediction for the origin of cancer, assessed by concordance rate | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have diagnosed invasive cancer or healthy volunteers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joohyuk Sohn | Contact | +82-2-2228-8135 | oncosohn@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Joohyuk Sohn | Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cancer Center, Yonsei Univ. College of Medicine | Recruiting | Seoul | South Korea |
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