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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorYonsei University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

4,000 Participants
are grouped into 2 trial groups

Sponsors and collaborators