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2024-08-21
2029-07-28
2029-07-28
1200
NCT07035587
Yonsei University
Yonsei University
OBSERVATIONAL
Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques
This is a combined prospective and retrospective observational study aiming to validate a highly sensitive and specific blood-based method for the early diagnosis and post-treatment monitoring of multiple cancers. The study leverages a newly developed sequencing method to improve the detection of circulating tumor DNA (ctDNA) in blood, focusing on enhancing sensitivity and specificity in clinical applications. The study targets patients with ovarian, lung, pancreatic, colorectal, esophageal, breast, kidney, bladder, and gastric cancer, as well as healthy controls with asymptomatic gallstones, benign polyps, or individuals undergoing routine medical screening. Blood samples will be analyzed for cell-free DNA (cfDNA), RNA, and protein profiles. A key objective is to determine how much the newly developed method increases the sensitivity and specificity of ctDNA detection, especially in early-stage cancers and minimal residual disease (MRD) after treatment. The method evaluates the variant allele frequency (VAF) of ctDNA to detect residual disease and track tumor dynamics. Serial blood sampling will be conducted before and after surgery or chemotherapy and during follow-up outpatient visits in cancer patients, while one-time sampling will be done for controls. Additionally, tissue biopsies collected during surgery will be used to analyze concordance between tumor-specific mutations and those found in ctDNA. Primary outcome measures include quantitative differences in ctDNA or RNA levels between cancer and control groups. Secondary outcomes assess the clinical correlation between changes in ctDNA VAF and patient outcomes such as recurrence and survival. Statistical tools including ROC curve analysis, Cox regression, and log-rank tests will be used to quantify performance. This study seeks to establish a clinically robust, non-invasive diagnostic tool that enables earlier detection and more precise treatment decisions, while potentially reducing physical, psychological, and socioeconomic burdens related to cancer care.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-06-15 | N/A | 2025-06-15 |
2025-06-15 | N/A | 2025-06-25 |
2025-06-25 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Cancer Patient Group Patients diagnosed with stage I-IV pancreatic, lung, colorectal, ovarian, esophageal, gastric, hematologic, breast, renal, bladder, or prostate cancer, including those undergoing surgery or chemotherapy. Blood samples will be collected serially before and | OTHER: Serial Blood Sampling for Molecular Profiling
|
| : Control Group Healthy individuals or patients with asymptomatic gallstones or benign colon polyps, or those undergoing routine health screening without a history of cancer. A single blood sample will be collected for cfDNA, RNA, and protein analysis. These samples will | OTHER: One-Time Blood Sampling for Molecular Profiling
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Difference in significantly detected ctDNA Variant Allele Frequency (VAF) between Cancer Patients and Controls | Quantitative measurement of significantly detected ctDNA variant allele frequency (VAF) in plasma samples from blood collected at baseline and follow-up visits (every 3-12 months up to 2 years) will be used to assess sensitivity and specificity of the developed sequencing method in detecting cancer-associated mutations. ROC curve analysis will be applied to determine the method's diagnostic performance (e.g., AUC). | At baseline and up to 66 months post-enrollment |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Correlation between ctDNA VAF and Clinical Outcomes (Recurrence and Survival) | To evaluate the relationship between ctDNA variant allele frequency (VAF) changes and patient clinical outcomes, including recurrence free and overall survival. Longitudinal VAF trends will be correlated with disease progression. Additionally, concordance between ctDNA mutations and matched tumor tissue mutations will be assessed. In patients receiving chemotherapy, detection of resistance-related mutations in ctDNA will be evaluated for associations with treatment outcomes. Survival analysis will use Cox regression and log-rank tests. | Baseline and follow-up at 3-12 month intervals, up to 36 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Hyongbum Henry Kim, MD Phone Number: +82-2-2228-1802 Email: aquamd@gmail.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
