๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.