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

Summary

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.

Eligibility

Inclusion Criteria:

1. Adults aged 19 years or older
2. Individuals who understand the study and voluntarily provide informed consent.
3. (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.).
4. (only for non-cancer participants) Individuals with no prior history of cancer.
5. (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.

Exclusion Criteria:

1. Pregnancy (self-reported pregnancy status).
2. Individuals for whom blood collection is deemed difficult by the investigator.
3. Individuals with a history of infection with HIV, HTLV, or syphilis.
4. (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).
5. (only for non-cancer participants) Individuals with cancer of unknown primary origin.
6. (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.

Conditions2

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