NCT07598747 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
| NCT ID | NCT07598747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gon Kim |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2029-10-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2024-10-14 with a primary completion date of 2029-10-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07598747 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07598747 currently recruiting?
Yes, NCT07598747 is actively recruiting participants. Contact the research team at inspector@yuhs.ac for enrollment information.
Where is the NCT07598747 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07598747 clinical trial?
NCT07598747 is sponsored by Chang Gon Kim. The trial plans to enroll 6,000 participants.
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