Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects

Recruiting now

Conditions studied: Cancer, Healthy Participants

In brief

This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. This study was designed to establish a clinical and molecular database using circulating DNA from both cancer patients and non-cancer participants, advance and validate an artificial intelligence platform capable of detecting various types of cancer at an early stage, and evaluate its performance.

Key facts

Study ID

NCT07598747

Run by

Chang Gon Kim

People needed

6000

Starts

2024-10-14

Expected to finish

2032-10-13

Last updated by the study team

2026-05-20

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults aged 19 years or older
• Individuals who understand the study and voluntarily provide informed consent.
• (only for cancer participants) Participants with newly diagnosed solid tumors (Stage I-IV, including brain tumors) or hematologic malignancies who:
• Have a histologically confirmed diagnosis (including bone marrow biopsy), or
• Are highly suspected of having cancer based on clinical and/or radiologic evaluation and are scheduled for surgical resection after blood collection; and
• Have not yet initiated any treatment (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, surgical resection, etc.).
• (only for non-cancer participants) Individuals with no prior history of cancer.
• (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.

You may not qualify if…

• Pregnancy (self-reported pregnancy status).
• Individuals for whom blood collection is deemed difficult by the investigator.
• Individuals with a history of infection with HIV, HTLV, or syphilis.
• (only for non-cancer participants) Individuals diagnosed with another malignancy within the past 5 years (exceptions: non-melanoma skin cancer, in-situ malignancies, thyroid cancer, and cervical intraepithelial neoplasia treated with curative intent).
• (only for non-cancer participants) Individuals with cancer of unknown primary origin.
• (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.

Where it is running

• Yonsei Cancer Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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