High-sensitivity blood test to detect and monitor multiple cancers
Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques
Yonsei University · NCT07035587
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 |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07035587 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Neoplasm Micrometastasis, Neoplasms