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

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

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.

Written informed consent will be obtained from each participant, and screening will begin after obtaining consent according to the study's inclusion and exclusion criteria.

The informed consent form (ICF) approved by each institution's IRB/EC must be used, and a copy of the signed ICF will be provided to the participant.

For participants who meet the eligibility criteria (meeting all inclusion criteria and none of the exclusion criteria), 20 mL of peripheral whole blood will be collected via standard venipuncture; the time of blood collection will be considered the time of study enrollment.

The collected 20 mL of blood will be divided into two Streck tubes (approximately 10 mL per tube) and must be handled, stored, and submitted according to the most recent laboratory manual.

Cancer participants: Blood will be collected before initiation of any treatment (surgery, chemotherapy, etc.) following cancer diagnosis.

Non-cancer participants: Blood will be collected during routine health examinations.

For domestic (Korean) cases, collected specimens should be stored at room temperature and transported as whole blood (without centrifugation) to the location designated by the sponsor by the following day after collection.

Clinical data of participants (cancer patients and healthy adults)-including sex, age, race, medical history, laboratory tests, imaging, and pathology results-will be collected in the electronic case report form (eCRF).

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.