Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detect… (NCT07598747) | Clinical Trial Compass
RecruitingNot Applicable
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
South Korea6,000 participantsStarted 2024-10-14
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged 19 years or older
. Individuals who understand the study and voluntarily provide informed consent.
. (only for cancer participants) Participants with newly diagnosed solid tumors (Stage I-IV, including brain tumors) or hematologic malignancies who:
. (only for non-cancer participants) Individuals with no prior history of cancer.
. (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.
Exclusion criteria
. Pregnancy (self-reported pregnancy status).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test.
. Individuals for whom blood collection is deemed difficult by the investigator.
. Individuals with a history of infection with HIV, HTLV, or syphilis.
. (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).
. (only for non-cancer participants) Individuals with cancer of unknown primary origin.
. (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.