Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07035587

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lung Neoplasms Adnexal Diseases Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Neoplasm Metastasis Neoplasm Micrometastasis Neoplasms Neoplasms by Site Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pharmacology, Yonsei University College of Medicine

Seoul, South Korea

Location status: Recruiting

Location contact

Hyongbum Henry Kim, M.D.

CONTACT

[email protected]

+82-2-2228-1802

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serial Blood Sampling for Molecular Profiling

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.

One-Time Blood Sampling for Molecular Profiling

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.

Primary outcomes

  1. Difference in significantly detected ctDNA Variant Allele Frequency (VAF) between Cancer Patients and Controls

    Time frame: At baseline and up to 66 months post-enrollment

    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).

Secondary outcomes

  1. Correlation between ctDNA VAF and Clinical Outcomes (Recurrence and Survival)

    Time frame: Baseline and follow-up at 3-12 month intervals, up to 36 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyongbum Henry Kim, MD

CONTACT

[email protected]

+82-2-2228-1802

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.