Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques

NCT ID: NCT07035587

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-21
• Study Completion Date: 2029-07-28

Brief Summary

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.

Conditions

Lung Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Ovarian Neoplasms; Stomach Neoplasms; Neoplasm Micrometastasis; Neoplasms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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 after treatment and during outpatient follow-up visits. Samples will be analyzed for circulating tumor DNA (ctDNA), cell-free DNA (cfDNA), RNA, and protein profiles to monitor tumor dynamics and evaluate diagnostic accuracy. Tissue biopsies will be used to compare tumor-specific mutations with those detected in ctDNA.

Serial Blood Sampling for Molecular Profiling

Intervention Type: OTHER

Cancer patients will undergo serial peripheral blood sampling at baseline (prior to surgery or chemotherapy), after treatment, and during follow-up visits. Blood samples will be analyzed for circulating tumor DNA (ctDNA), cell-free DNA (cfDNA), RNA, and protein biomarkers. The purpose is to detect variant allele frequency (VAF) and evaluate its relationship with tumor dynamics and treatment outcomes, including recurrence and survival.

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 serve as comparators to assess molecular differences between non-cancer and cancer populations.

One-Time Blood Sampling for Molecular Profiling

Intervention Type: OTHER

Control participants, including individuals with asymptomatic gallstones, benign polyps, or those undergoing health screening, will provide a one-time peripheral blood sample. The sample will be analyzed for cfDNA, RNA, and protein biomarkers and used as a baseline reference to compare molecular characteristics between non-cancer and cancer groups.

Interventions

Serial Blood Sampling for Molecular Profiling

Cancer patients will undergo serial peripheral blood sampling at baseline (prior to surgery or chemotherapy), after treatment, and during follow-up visits. Blood samples will be analyzed for circulating tumor DNA (ctDNA), cell-free DNA (cfDNA), RNA, and protein biomarkers. The purpose is to detect variant allele frequency (VAF) and evaluate its relationship with tumor dynamics and treatment outcomes, including recurrence and survival.

Intervention Type: OTHER

One-Time Blood Sampling for Molecular Profiling

Control participants, including individuals with asymptomatic gallstones, benign polyps, or those undergoing health screening, will provide a one-time peripheral blood sample. The sample will be analyzed for cfDNA, RNA, and protein biomarkers and used as a baseline reference to compare molecular characteristics between non-cancer and cancer groups.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Pharmacology, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyongbum Henry Kim, MD

Role: CONTACT

aquamd@gmail.com

+82-2-2228-1802

Facility Contacts

Hyongbum Henry Kim, M.D.

Role: primary

aquamd@gmail.com

+82-2-2228-1802

Other Identifiers

4-2024-0702

Identifier Type: -

Identifier Source: org_study_id