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
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.
Yonsei University
4,000 participants
Oct 13, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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)
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06231953