High-sensitivity blood test to detect and monitor multiple cancers
Official title: Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques
Run by Yonsei University · NCT07035587 · Data updated 2026-11-12
This study will test a high-sensitivity blood test that looks for tumor DNA to detect and follow several common cancers in adults with those cancers or people having routine health screenings.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | August 21, 2024 |
| Main results expected | July 28, 2029 |
| Study ends | July 28, 2029 |
| Registry record updated | June 25, 2025 |
| Trial ID | NCT07035587 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥19) diagnosed with ovarian, lung, pancreatic, colorectal, esophageal, breast, bladder, kidney, or gastric cancer who have had or will have surgery or chemotherapy, as well as asymptomatic adults with benign imaging findings or those undergoing routine health screening for the control group.
✕Probably not a fit
Patients younger than 19, those unable to give informed consent, individuals with recent other malignancies, or cancer patients whose tumor or pre-treatment cfDNA shows no detectable somatic mutation may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This combined prospective and retrospective observational study uses a newly developed high-sensitivity sequencing method to detect circulating tumor DNA (ctDNA) and other blood biomarkers (cfDNA, RNA, proteins). Participants include adults with specified cancers and control participants with benign imaging findings or undergoing routine screening. Blood is collected either one time or serially to compare the new method's sensitivity and specificity for early-stage cancer detection and for monitoring minimal residual disease after treatment. The main aim is to quantify how much the new sequencing approach improves ctDNA detection compared with current methods.
Why it matters
Potential benefit: If successful, the test could enable earlier detection of some cancers and more accurate, less invasive tracking of minimal residual disease after treatment using blood samples.
How similar studies have gone: Prior liquid biopsy studies using ctDNA have shown promise for monitoring and prognosis but have limited sensitivity for early-stage cancers and MRD, so this high-sensitivity sequencing approach is relatively novel and aims to improve on those limitations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 19 years * Voluntarily agreed to participate and provided informed consent * Able to donate blood without health risks * Underwent or is scheduled to undergo surgery or chemotherapy for therapeutic purposes for cancer (for cancer group) * Diagnosed with one of the following cancers: ovarian, lung, pancreatic, colorectal, esophageal, breast, bladder, kidney, or gastric cancer * Control group: asymptomatic individuals with gallstones or benign polyps, or subjects undergoing routine health screenings * Control group must have confirmed benign findings through imaging (ultrasound, CT, LDCT, colonoscopy) Exclusion Criteria: * Age \< 19 years * Patients with mental retardation or severe psychiatric disorders affecting informed consent * History of HIV, HTLV, or syphilis infection * History of other malignancy within 5 years (for cancer group) * No somatic mutation detected in tumor or pre-treatment cfDNA (for cancer group) * Control group with any past or current cancer diagnosis * Control group with high-grade adenoma, symptomatic gallstones/polyps, or recent (\<6 months) abdominal surgery * Pregnant or breastfeeding women * Any other reason deemed inappropriate by the investigator
Where it's running
-
Department of Pharmacology, Yonsei University College of Medicine
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Hyongbum Henry Kim, MD
- Email: aquamd@gmail.com
- Phone: +82-2-2228-1802
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.