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.
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 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)
Subjects who have diagnosed invasive cancer or healthy volunteers
Cohort
Prospective
Not listed
Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value
Accuracy of prediction for the origin of cancer, assessed by concordance rate
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