Multi-Cancer Early Detection using blood DNA sequencing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center observational study that collects blood and clinical data from adults with newly diagnosed solid or hematologic cancers and from healthy participants. The goal is to build a clinical and molecular database from circulating DNA and to develop and validate an AI platform that can detect multiple cancers at early stages. Participants provide informed consent, have blood drawn into Streck tubes, and data are managed in an electronic case report form. Cancer patients are enrolled before any treatment, while healthy volunteers are enrolled during routine health assessments. Specimens are stored and transported per protocol, and imaging data may be collected as part of eligibility assessment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yonsei Cancer Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Chang Gon Kim
• Email: inspector@yuhs.ac
• Phone: +82-2-2228-8130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.