Lung NeoplasmsNCT07035587
Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques
An observational study of Lung Neoplasms and Pancreatic Neoplasms, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms
- What is being tested?
- Serial Blood Sampling for Molecular Profiling and One-Time Blood Sampling for Molecular Profiling
- Type of treatment
- Injection or infusion
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Aug 2024to 28 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from patients and screening subjects at Yonsei University Health System (Severance Hospital, Yonsei Cancer Center, and affiliated check-up centers in Seoul, South Korea). The study population includes individuals diagnosed with ovarian, lung, pancreatic, colorectal, esophageal, breast, bladder, kidney, or gastric cancers, either newly diagnosed or post-treatment. The control group includes individuals with asymptomatic gallstones, benign polyps, or those undergoing routine health screenings. All participants must be 19 years or older and able to provide informed consent for blood collection and data/sample usage.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Pharmacology, Yonsei University College of Medicine
Seoul
Hyongbum Henry Kim, M.D., +82-2-2228-1802, aquamd@gmail.com
About this study
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.
Read more
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
- Being tested
- Serial Blood Sampling for Molecular Profiling, One-Time Blood Sampling for Molecular Profiling
- Medical subject headings
- Lung Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Neoplasm Micrometastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial Blood Sampling for Molecular ProfilingOther
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 ProfilingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 serve as comparators to assess molecular differences between non-cancer and cancer populations. Receives: Other: One-Time Blood Sampling for Molecular Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and up to 66 months post-enrollment
Secondary outcomes (1)
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.
Measured: Baseline and follow-up at 3-12 month intervals, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start21 Aug 2024
- Primary completion28 Jul 2029 (estimated)
- Study completion28 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035587
- Sponsor's protocol ID
- 4-2024-0702
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques
- ClinicalTrials.gov ID
- NCT07035587
- Acronym / sponsor ID
- 4-2024-0702
- Conditions
- Lung Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Ovarian Neoplasms, Stomach Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 28 Jul 2029 (estimated)
- Study completion
- 28 Jul 2029 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Patient Group | – | Other: Serial Blood Sampling for Molecular ProfilingPatients 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. |
| Control Group | – | Other: One-Time Blood Sampling for Molecular ProfilingHealthy 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from patients and screening subjects at Yonsei University Health System (Severance Hospital, Yonsei Cancer Center, and affiliated check-up centers in Seoul, South Korea). The study population includes individuals diagnosed with ovarian, lung, pancreatic, colorectal, esophageal, breast, bladder, kidney, or gastric cancers, either newly diagnosed or post-treatment. The control group includes individuals with asymptomatic gallstones, benign polyps, or those undergoing routine health screenings. All participants must be 19 years or older and able to provide informed consent for blood collection and data/sample usage.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial Blood Sampling for Molecular ProfilingCancer 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. | Other | Cancer Patient Group |
| One-Time Blood Sampling for Molecular ProfilingControl 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. | Other | Control Group |
Primary outcome
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).
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Pancreatic Neoplasms, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyongbum Henry Kim, MD (+82-2-2228-1802, aquamd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.