Ovarian NeoplasmsNCT07670962
Blood-Based Minimal Residual Disease in Advanced Epithelial Ovarian Cancer After 1st Line Therapy
An observational study of Ovarian Neoplasms and Carcinoma, Ovarian Epithelial, run by Asan Medical Center.
Trial summary
The purpose of this observational study is to learn if a specialized blood test can help predict whether advanced ovarian cancer will return after a patient's initial treatments are finished. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Ovarian Cancer
- What is being tested?
- Blood-based ctDNA minimal residual disease (MRD) test
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2028
- How long will I take part?
- 3 Years
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult women (aged 19 years or older) diagnosed with FIGO stage III or IV advanced epithelial ovarian cancer, specifically including high-grade serous, endometrioid, clear cell, or mixed carcinomas. To be eligible, patients must have successfully completed their standard first-line therapy, consisting of primary debulking surgery (PDS) or interval debulking surgery (IDS) paired with platinum-based chemotherapy, and must have achieved a clinical or radiological complete response (CR) at the end of treatment. A total of 200 patients meeting these criteria will be enrolled in this prospective cohort.
Who may be able to join
- Women aged 19 years or older. Pathologically confirmed high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer.
- FIGO stage III or IV. Patients who have completed primary debulking surgery (PDS) or interval debulking surgery (IDS) and platinum-based chemotherapy (subsequent maintenance therapy, such as bevacizumab or PARP inhibitors, is allowed).
- Patients showing radiological or clinical Complete Response (CR) after the completion of platinum-based chemotherapy.
- Written informed consent for the study.
Who cannot join
- Radiological progressive disease during or immediately after treatment. Expected survival of 3 months or less. Immunodeficiency or pathological bleeding tendencies. Unable to undergo blood tests or unwilling to undergo repeated blood sampling. Concurrent other solid tumors or history of malignant tumors within the last 5 years.
- Refusal to consent to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Role of Blood-Based Minimal Residual Disease in Patients With Advanced Epithelial Ovarian Cancer After 1st Line Therapy
The purpose of this observational study is to learn if a specialized blood test can help predict whether advanced ovarian cancer will return after a patient's initial treatments are finished.
Researchers are inviting women who have been diagnosed with stage III or IV epithelial ovarian cancer and have recently completed their first-line treatments, which include surgery and platinum-based chemotherapy.
Read more
The study focuses on "circulating tumor DNA" (ctDNA), which are tiny fragments of genetic material that cancer cells release into the bloodstream as they break down. Finding these DNA fragments in the blood when a patient appears to be cancer-free on standard tests is known as assessing for minimal residual disease (MRD).
Because this is an observational study, participants will receive standard medical care as directed by their doctor. For the research portion, participants will provide blood samples at specific times: at the time of diagnosis, shortly after surgery, right after finishing their first-line chemotherapy, and then every 3 months during regular follow-up visits. Researchers will also analyze a sample of the tumor tissue that was already removed during the patient's standard surgery.
By tracking these participants for up to 3 years, researchers hope to discover if the ctDNA test can accurately identify patients who have a high risk of their cancer returning, and if it can detect this earlier than traditional imaging scans or standard blood tests like CA-125.
Read the detailed description
Despite high initial response rates to standard first-line therapies (surgery and platinum-based chemotherapy), the majority of patients with advanced high-grade epithelial ovarian cancer experience recurrence within three years. Traditional surveillance methods, including the CA-125 tumor marker and radiological imaging, often lack the sensitivity required to detect minimal residual disease (MRD) at a molecular level, limiting the window for early therapeutic intervention. Circulating tumor DNA (ctDNA) analysis has emerged as a promising, non-invasive technology capable of reflecting tumor-specific genetic mutations and real-time molecular profiling.
This prospective, non-interventional cohort study aims to comprehensively evaluate the clinical utility of blood-based ctDNA as an independent biomarker for predicting recurrence in patients with FIGO stage III-IV epithelial ovarian cancer. The primary objective is to determine whether the presence of ctDNA (MRD positivity) measured immediately after the completion of standard first-line therapy correlates significantly with Relapse-Free Survival (RFS).
To establish a baseline mutational profile, tumor tissue obtained during initial biopsy or debulking surgery (primary or interval) will undergo Next-Generation Sequencing (NGS). Longitudinally, peripheral blood samples (20 mL) will be collected at predefined critical time points: at initial diagnosis (prior to treatment), post-surgery, within 2-4 weeks after the completion of first-line adjuvant or maintenance therapy (baseline for post-treatment MRD), and every 3 months during the follow-up period for up to 36 months or until disease recurrence.
Cell-free DNA (cfDNA) will be extracted from the collected plasma and analyzed using a highly sensitive, validated NGS-based multigene panel (AlphaLiquid® 100). The analysis will quantify major genetic variants (Variant Allele Frequency [VAF] ≥ 0.1%).
By tracking changes in ctDNA dynamics and comparing them with standard follow-up modalities, the study will investigate the lead time of ctDNA detection over radiological recurrence and compare its sensitivity and specificity against CA-125. Ultimately, this research seeks to provide robust scientific evidence to support the integration of ctDNA-based MRD monitoring into standard surveillance protocols, potentially enabling personalized tracking strategies and earlier clinical decision-making for high-risk ovarian cancer patients.
- Being tested
- Blood-based ctDNA minimal residual disease (MRD) test
- Keywords
- ctDNA, Minimal Residual Disease, MRD, Liquid Biopsy
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood-based ctDNA minimal residual disease (MRD) testDiagnostic test
A non-invasive diagnostic blood test designed to monitor minimal residual disease (MRD). The procedure involves extracting cell-free DNA (cfDNA) from peripheral blood plasma and performing Next-Generation Sequencing (NGS) using a validated multigene assay (AlphaLiquid 100). This test detects and quantifies tumor-specific genetic mutations (Variant Allele Frequency [VAF] ≥ 0.1%) to evaluate molecular-level recurrence after the completion of standard first-line therapy.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Epithelial Ovarian Cancer Cohort | Patients with FIGO stage III-IV high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer who have completed primary or interval debulking surgery and platinum-based chemotherapy, and show a complete response. This cohort will undergo non-invasive blood-based minimal residual disease (MRD) monitoring using an NGS-based ctDNA assay (AlphaLiquid®100) to evaluate its utility in predicting recurrence. Receives: Diagnostic Test: Blood-based ctDNA minimal residual disease (MRD) test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival (RFS) according to ctDNA Minimal Residual Disease (MRD) status
Relapse-Free Survival (RFS) is defined as the time from the completion of standard first-line therapy to the date of the first documented radiological or clinical disease recurrence, or death from any cause. This measure evaluates the correlation between ctDNA positivity (baseline MRD status, measured within 2-4 weeks after completing 1st-line therapy) and RFS. The median RFS and Hazard Ratio (HR) will be compared between the ctDNA-positive and ctDNA-negative patient groups.
Measured: Up to 36 months (From the completion of first-line therapy until documented recurrence or the end of the study follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Yeol Park, MD, PhD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670962
- Sponsor's protocol ID
- 2026-0409
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared with other researchers to strictly protect patient privacy and confidentiality. According to the study protocol and institutional regulations, access to all research data is strictly limited to the principal investigator and the minimum number of authorized research personnel approved by the Institutional Review Board (IRB). All collected data is coded to prevent external exposure of any personally identifiable information. Furthermore, in compliance with South Korea's Bioethics and Safety Act and Personal Information Protection Act, all study-related records will be securely retained for 3 years after the completion of the study and subsequently permanently destroyed, which precludes external data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Blood-Based Minimal Residual Disease in Patients With Advanced Epithelial Ovarian Cancer After 1st Line Therapy
- ClinicalTrials.gov ID
- NCT07670962
- Acronym / sponsor ID
- 2026-0409
- Keywords
- ctDNA, Minimal Residual Disease, MRD, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Jun 2026 (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.
The purpose of this observational study is to learn if a specialized blood test can help predict whether advanced ovarian cancer will return after a patient's initial treatments are finished.
Researchers are inviting women who have been diagnosed with stage III or IV epithelial ovarian cancer and have recently completed their first-line treatments, which include surgery and platinum-based chemotherapy.
The study focuses on "circulating tumor DNA" (ctDNA), which are tiny fragments of genetic material that cancer cells release into the bloodstream as they break down. Finding these DNA fragments in the blood when a patient appears to be cancer-free on standard tests is known as assessing for minimal residual disease (MRD).
Because this is an observational study, participants will receive standard medical care as directed by their doctor. For the research portion, participants will provide blood samples at specific times: at the time of diagnosis, shortly after surgery, right after finishing their first-line chemotherapy, and then every 3 months during regular follow-up visits. Researchers will also analyze a sample of the tumor tissue that was already removed during the patient's standard surgery.
By tracking these participants for up to 3 years, researchers hope to discover if the ctDNA test can accurately identify patients who have a high risk of their cancer returning, and if it can detect this earlier than traditional imaging scans or standard blood tests like CA-125.
Detailed description
Despite high initial response rates to standard first-line therapies (surgery and platinum-based chemotherapy), the majority of patients with advanced high-grade epithelial ovarian cancer experience recurrence within three years. Traditional surveillance methods, including the CA-125 tumor marker and radiological imaging, often lack the sensitivity required to detect minimal residual disease (MRD) at a molecular level, limiting the window for early therapeutic intervention. Circulating tumor DNA (ctDNA) analysis has emerged as a promising, non-invasive technology capable of reflecting tumor-specific genetic mutations and real-time molecular profiling.
This prospective, non-interventional cohort study aims to comprehensively evaluate the clinical utility of blood-based ctDNA as an independent biomarker for predicting recurrence in patients with FIGO stage III-IV epithelial ovarian cancer. The primary objective is to determine whether the presence of ctDNA (MRD positivity) measured immediately after the completion of standard first-line therapy correlates significantly with Relapse-Free Survival (RFS).
To establish a baseline mutational profile, tumor tissue obtained during initial biopsy or debulking surgery (primary or interval) will undergo Next-Generation Sequencing (NGS). Longitudinally, peripheral blood samples (20 mL) will be collected at predefined critical time points: at initial diagnosis (prior to treatment), post-surgery, within 2-4 weeks after the completion of first-line adjuvant or maintenance therapy (baseline for post-treatment MRD), and every 3 months during the follow-up period for up to 36 months or until disease recurrence.
Cell-free DNA (cfDNA) will be extracted from the collected plasma and analyzed using a highly sensitive, validated NGS-based multigene panel (AlphaLiquid® 100). The analysis will quantify major genetic variants (Variant Allele Frequency [VAF] ≥ 0.1%).
By tracking changes in ctDNA dynamics and comparing them with standard follow-up modalities, the study will investigate the lead time of ctDNA detection over radiological recurrence and compare its sensitivity and specificity against CA-125. Ultimately, this research seeks to provide robust scientific evidence to support the integration of ctDNA-based MRD monitoring into standard surveillance protocols, potentially enabling personalized tracking strategies and earlier clinical decision-making for high-risk ovarian cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Epithelial Ovarian Cancer Cohort | – | Diagnostic Test: Blood-based ctDNA minimal residual disease (MRD) testPatients with FIGO stage III-IV high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer who have completed primary or interval debulking surgery and platinum-based chemotherapy, and show a complete response. This cohort will undergo non-invasive blood-based minimal residual disease (MRD) monitoring using an NGS-based ctDNA assay (AlphaLiquid®100) to evaluate its utility in predicting recurrence. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult women (aged 19 years or older) diagnosed with FIGO stage III or IV advanced epithelial ovarian cancer, specifically including high-grade serous, endometrioid, clear cell, or mixed carcinomas. To be eligible, patients must have successfully completed their standard first-line therapy, consisting of primary debulking surgery (PDS) or interval debulking surgery (IDS) paired with platinum-based chemotherapy, and must have achieved a clinical or radiological complete response (CR) at the end of treatment. A total of 200 patients meeting these criteria will be enrolled in this prospective cohort.
Key inclusion criteria (4 listed)
- Women aged 19 years or older. Pathologically confirmed high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer.
- FIGO stage III or IV. Patients who have completed primary debulking surgery (PDS) or interval debulking surgery (IDS) and platinum-based chemotherapy (subsequent maintenance therapy, such as bevacizumab or PARP inhibitors, is allowed).
- Patients showing radiological or clinical Complete Response (CR) after the completion of platinum-based chemotherapy.
- Written informed consent for the study.
Key exclusion criteria (2 listed)
- Radiological progressive disease during or immediately after treatment. Expected survival of 3 months or less. Immunodeficiency or pathological bleeding tendencies. Unable to undergo blood tests or unwilling to undergo repeated blood sampling. Concurrent other solid tumors or history of malignant tumors within the last 5 years.
- Refusal to consent to participate in this study.
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 |
|---|---|---|
| Blood-based ctDNA minimal residual disease (MRD) testA non-invasive diagnostic blood test designed to monitor minimal residual disease (MRD). The procedure involves extracting cell-free DNA (cfDNA) from peripheral blood plasma and performing Next-Generation Sequencing (NGS) using a validated multigene assay (AlphaLiquid 100). This test detects and quantifies tumor-specific genetic mutations (Variant Allele Frequency [VAF] ≥ 0.1%) to evaluate molecular-level recurrence after the completion of standard first-line therapy. | Diagnostic test | Advanced Epithelial Ovarian Cancer Cohort |
Primary outcome
Relapse-Free Survival (RFS) according to ctDNA Minimal Residual Disease (MRD) status
Time frame: Up to 36 months (From the completion of first-line therapy until documented recurrence or the end of the study follow-up period)
Relapse-Free Survival (RFS) is defined as the time from the completion of standard first-line therapy to the date of the first documented radiological or clinical disease recurrence, or death from any cause. This measure evaluates the correlation between ctDNA positivity (baseline MRD status, measured within 2-4 weeks after completing 1st-line therapy) and RFS. The median RFS and Hazard Ratio (HR) will be compared between the ctDNA-positive and ctDNA-negative patient groups.
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 26 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared with other researchers to strictly protect patient privacy and confidentiality. According to the study protocol and institutional regulations, access to all research data is strictly limited to the principal investigator and the minimum number of authorized research personnel approved by the Institutional Review Board (IRB). All collected data is coded to prevent external exposure of any personally identifiable information. Furthermore, in compliance with South Korea's Bioethics and Safety Act and Personal Information Protection Act, all study-related records will be securely retained for 3 years after the completion of the study and subsequently permanently destroyed, which precludes external data sharing.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Carcinoma, Ovarian Epithelial, run by Asan Medical Center.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jeong-Yeol Park, MD, PhD (+82-2-3010-3646, catgut1-0@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (RFS) according to ctDNA Minimal Residual Disease (MRD) status (time frame: Up to 36 months (From the completion of first-line therapy until documented recurrence or the end of the study follow-up period)). 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 26 Jun 2026.