Actively Recruiting
Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques
Led by Yonsei University · Updated on 2025-06-25
1200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to validate a highly sensitive and specific blood-based method for the early diagnosis and monitoring of multiple cancers, including ovarian, lung, pancreatic, colorectal, esophageal, breast, kidney, bladder, and gastric cancers. It focuses on improving detection of circulating tumor DNA (ctDNA) using a newly developed sequencing approach, with a goal to enhance early cancer detection and track minimal residual disease after treatment. Participants include cancer patients undergoing surgery or chemotherapy who will have multiple blood samples taken before treatment, after treatment, and during follow-up visits. Healthy controls or individuals with benign conditions or undergoing routine screenings will provide a single blood sample. Blood samples will be analyzed for circulating tumor DNA, cell-free DNA, RNA, and protein profiles. Tissue biopsies from cancer patients will be examined to compare tumor mutations with those found in blood. Participants will provide blood samples at various times to measure ctDNA variant allele frequency and its relationship to tumor changes and treatment outcomes, including recurrence and survival. The study will use statistical methods to assess diagnostic accuracy and clinical correlations. The total follow-up can extend up to 66 months, with primary outcomes focusing on differences in ctDNA levels between cancer and control groups. This study seeks to develop a non-invasive tool to support earlier detection and better treatment decisions while reducing burdens associated with cancer care.
CONDITIONS
Brief Title
Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Voluntarily agreed to participate and provided informed consent
- Able to donate blood without health risks
- Cancer group: diagnosed with ovarian, lung, pancreatic, colorectal, esophageal, breast, bladder, kidney, or gastric cancer
- Cancer group: undergoing or scheduled for surgery or chemotherapy
- Control group: asymptomatic individuals with gallstones or benign polyps, or undergoing routine health screening
- Control group: confirmed benign findings by imaging (ultrasound, CT, LDCT, colonoscopy)
You will not qualify if you...
- Under 19 years of age
- Mental retardation or severe psychiatric disorders affecting consent
- History of HIV, HTLV, or syphilis infection
- History of other malignancy within 5 years (cancer group)
- No somatic mutation detected in tumor or pre-treatment cfDNA (cancer group)
- Control group with any past or current cancer diagnosis
- Control group with high-grade adenoma, symptomatic gallstones/polyps, or abdominal surgery within 6 months
- Pregnant or breastfeeding women
- Any other reason deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline (prior to surgery or chemotherapy for cancer patients)
Blood samples are collected from participants to analyze circulating tumor DNA (ctDNA), cell-free DNA (cfDNA), RNA, and protein biomarkers to detect molecular characteristics and differences between cancer patients and controls.
1 visit (in-person) for controls; 1 visit (in-person) at baseline for cancer patients
Duration - Up to 66 months post-enrollment
Cancer patients undergo serial blood sampling after treatment and during outpatient follow-up visits to monitor tumor dynamics, recurrence, and survival outcomes through molecular profiling.
Follow-up visits at 3 to 12 month intervals for up to 66 months
Trial Site Locations
Total: 1 location
1
Department of Pharmacology, Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
Research Team
H
Hyongbum Henry Kim, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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