Uterine NeoplasmsNCT07382505
Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cervical Cancer
An observational study of Uterine Neoplasms and Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study aims to evaluate the clinical performance of blood-based Minimal Residual Disease (MRD) testing using circulating tumor DNA (ctDNA) in patients with endometrial and cervical cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Neoplasms, Cervical Cancer
- What is being tested?
- Serial blood collection for MRD testing
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2026to 31 Dec 2027
- How long will I take part?
- 2 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of female patients aged 19 to 79 who have been histologically diagnosed with either endometrial cancer or cervical cancer at Asan Medical Center. This cohort includes patients across various stages of the disease who are scheduled to undergo or have completed standard-of-care treatments, such as radical surgery, adjuvant chemotherapy, radiotherapy, or concurrent chemoradiotherapy (CCRT). The population is designed to represent a real-world clinical setting of gynecologic oncology patients to evaluate the effectiveness of MRD monitoring in predicting recurrence and survival outcomes.
Who may be able to join
- Histologically confirmed endometrial cancer or cervical cancer.
- Scheduled for or completed standard treatment (Surgery, Adjuvant therapy, or CCRT).
- Provision of written informed consent for study participation and biospecimen collection
Who cannot join
- Synchronous other malignancies (cancer requiring treatment within the last 5 years).
- Persistent infection or bleeding tendency that makes repeated blood collection unsafe.
- Inability to follow-up or communicate (e.g., due to geographic or cognitive reasons).
- Any condition that the principal investigator deems inappropriate for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Cohort to Evaluate the Prognostic and Early-Recurrence Detection Performance of Blood-based Minimal Residual Disease (MRD) Testing in Endometrial and Cervical Cancer
This study aims to evaluate the clinical performance of blood-based Minimal Residual Disease (MRD) testing using circulating tumor DNA (ctDNA) in patients with endometrial and cervical cancer. The researchers will investigate whether MRD detection can identify cancer recurrence earlier than current standard imaging or clinical methods (providing a "lead time"). Participants will undergo blood collection at specific time points, including at diagnosis, after surgery, and during regular follow-up visits. The study will also assess the correlation between MRD status and survival outcomes, such as Relapse-Free Survival (RFS) and Overall Survival (OS). The goal is to establish a foundation for personalized treatment strategies based on molecular monitoring.
Read the detailed description
Despite standard treatments, a significant number of patients with endometrial and cervical cancer experience recurrence. Current monitoring relies on imaging (CT/MRI) and tumor markers (CA-125, SCC-Ag), which often detect recurrence only after a visible tumor mass has formed. This prospective cohort study evaluates the utility of ctDNA-based MRD testing as a high-sensitivity biomarker for early detection.
Study Population and Workflow: A total of 600 participants (300 with endometrial cancer and 300 with cervical cancer) will be enrolled. The study involves the following procedures:
Tumor Tissue Collection: Formalin-fixed paraffin-embedded (FFPE) tissue from surgery or biopsy will be collected for genomic profiling.
Serial Blood Collection: Peripheral blood samples (approximately 20ml) will be collected at:
Baseline (before surgery or CCRT)
Post-operative (within 4 weeks after surgery)
Post-adjuvant therapy (within 4 weeks after completion of chemotherapy or CCRT)
Surveillance (every 3 months for the first 2 years, then every 6 months)
MRD Analysis: Deep sequencing of plasma cell-free DNA (cfDNA) will be performed to track tumor-specific variants.
Objectives: The primary objective is to calculate the "lead time," defined as the interval between the first MRD-positive result and clinical/radiological recurrence. Secondary objectives include evaluating the sensitivity and specificity of the MRD assay and its association with RFS and OS. By comparing MRD dynamics with conventional biomarkers, this study seeks to determine if molecular monitoring can provide a more accurate assessment of a patient's prognosis and risk of relapse.
- Conditions
- Uterine Neoplasms, Cervical Cancer
- Being tested
- Serial blood collection for MRD testing
- Keywords
- Endometrial Cancer, Cervical Cancer, Minimal Residual Disease, MRD, Circulating Tumor DNA, Liquid Biopsy
- Medical subject headings
- Uterine Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial blood collection for MRD testingGenetic
Participants will undergo serial peripheral blood collection (approximately 20 mL per visit) at predefined clinical milestones: baseline (diagnosis), post-operative (2-4 weeks after surgery), post-adjuvant therapy (2-4 weeks after completion of chemotherapy or CCRT), and during follow-up surveillance (every 3 months for up to 24 months).
The collected blood will be used to perform Minimal Residual Disease (MRD) testing by analyzing circulating tumor DNA (ctDNA).
Archival tumor tissue (FFPE blocks or slides) from initial diagnosis or surgery will also be collected to identify patient-specific somatic mutations for the MRD assay.
This study is observational and does not involve any changes to the patient's standard of care or medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| endometrial cancer cohort | patients diagnosed with endometrial cancer Receives: Genetic: Serial blood collection for MRD testing | |
| cervical cancer cohort | patients diagnosed with cervical cancer Receives: Genetic: Serial blood collection for MRD testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Evaluation of the association between MRD status (detected vs. not detected) and the risk of recurrence or death. MRD will be analyzed as a time-dependent covariate in a Cox proportional hazards model.
Measured: From the date of enrollment until the date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 48 months.
Secondary outcomes (2)
Sensitivity and Specificity of MRD Assay
Evaluation of the diagnostic performance metrics, including sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of ctDNA-based MRD testing for predicting clinical recurrence.
Measured: Assessed at specific landmarks (e.g., post-surgery and completion of adjuvant therapy) up to 48 months.
Overall Survival (OS)
Comparison of the overall survival rate between patients with MRD-positive and MRD-negative results using the Hazard Ratio (HR).
Measured: From the date of enrollment until the date of death from any cause, assessed up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine 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
- 600 participants (estimated)
- Target duration
- 2 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
- NCT07382505
- Sponsor's protocol ID
- Seoul Asan Medical Center
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort to Evaluate the Prognostic and Early-Recurrence Detection Performance of Blood-based Minimal Residual Disease (MRD) Testing in Endometrial and Cervical Cancer
- ClinicalTrials.gov ID
- NCT07382505
- Acronym / sponsor ID
- Seoul Asan Medical Center
- Conditions
- Uterine Neoplasms, Cervical Cancer
- Keywords
- Endometrial Cancer, Cervical Cancer, Minimal Residual Disease, MRD, Circulating Tumor DNA, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 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.
This study aims to evaluate the clinical performance of blood-based Minimal Residual Disease (MRD) testing using circulating tumor DNA (ctDNA) in patients with endometrial and cervical cancer. The researchers will investigate whether MRD detection can identify cancer recurrence earlier than current standard imaging or clinical methods (providing a "lead time"). Participants will undergo blood collection at specific time points, including at diagnosis, after surgery, and during regular follow-up visits. The study will also assess the correlation between MRD status and survival outcomes, such as Relapse-Free Survival (RFS) and Overall Survival (OS). The goal is to establish a foundation for personalized treatment strategies based on molecular monitoring.
Detailed description
Despite standard treatments, a significant number of patients with endometrial and cervical cancer experience recurrence. Current monitoring relies on imaging (CT/MRI) and tumor markers (CA-125, SCC-Ag), which often detect recurrence only after a visible tumor mass has formed. This prospective cohort study evaluates the utility of ctDNA-based MRD testing as a high-sensitivity biomarker for early detection.
Study Population and Workflow: A total of 600 participants (300 with endometrial cancer and 300 with cervical cancer) will be enrolled. The study involves the following procedures:
Tumor Tissue Collection: Formalin-fixed paraffin-embedded (FFPE) tissue from surgery or biopsy will be collected for genomic profiling.
Serial Blood Collection: Peripheral blood samples (approximately 20ml) will be collected at:
Baseline (before surgery or CCRT)
Post-operative (within 4 weeks after surgery)
Post-adjuvant therapy (within 4 weeks after completion of chemotherapy or CCRT)
Surveillance (every 3 months for the first 2 years, then every 6 months)
MRD Analysis: Deep sequencing of plasma cell-free DNA (cfDNA) will be performed to track tumor-specific variants.
Objectives: The primary objective is to calculate the "lead time," defined as the interval between the first MRD-positive result and clinical/radiological recurrence. Secondary objectives include evaluating the sensitivity and specificity of the MRD assay and its association with RFS and OS. By comparing MRD dynamics with conventional biomarkers, this study seeks to determine if molecular monitoring can provide a more accurate assessment of a patient's prognosis and risk of relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometrial cancer cohort | – | Genetic: Serial blood collection for MRD testingpatients diagnosed with endometrial cancer |
| cervical cancer cohort | – | Genetic: Serial blood collection for MRD testingpatients diagnosed with cervical cancer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of female patients aged 19 to 79 who have been histologically diagnosed with either endometrial cancer or cervical cancer at Asan Medical Center. This cohort includes patients across various stages of the disease who are scheduled to undergo or have completed standard-of-care treatments, such as radical surgery, adjuvant chemotherapy, radiotherapy, or concurrent chemoradiotherapy (CCRT). The population is designed to represent a real-world clinical setting of gynecologic oncology patients to evaluate the effectiveness of MRD monitoring in predicting recurrence and survival outcomes.
Key inclusion criteria (3 listed)
- Histologically confirmed endometrial cancer or cervical cancer.
- Scheduled for or completed standard treatment (Surgery, Adjuvant therapy, or CCRT).
- Provision of written informed consent for study participation and biospecimen collection
Key exclusion criteria (4 listed)
- Synchronous other malignancies (cancer requiring treatment within the last 5 years).
- Persistent infection or bleeding tendency that makes repeated blood collection unsafe.
- Inability to follow-up or communicate (e.g., due to geographic or cognitive reasons).
- Any condition that the principal investigator deems inappropriate for the 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 |
|---|---|---|
| Serial blood collection for MRD testingParticipants will undergo serial peripheral blood collection (approximately 20 mL per visit) at predefined clinical milestones: baseline (diagnosis), post-operative (2-4 weeks after surgery), post-adjuvant therapy (2-4 weeks after completion of chemotherapy or CCRT), and during follow-up surveillance (every 3 months for up to 24 months). The collected blood will be used to perform Minimal Residual Disease (MRD) testing by analyzing circulating tumor DNA (ctDNA). Archival tumor tissue (FFPE blocks or slides) from initial diagnosis or surgery will also be collected to identify patient-specific somatic mutations for the MRD assay. This study is observational and does not involve any changes to the patient's standard of care or medical treatment. | Genetic | cervical cancer cohort, endometrial cancer cohort |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the date of enrollment until the date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 48 months.
Evaluation of the association between MRD status (detected vs. not detected) and the risk of recurrence or death. MRD will be analyzed as a time-dependent covariate in a Cox proportional hazards model.
2 secondary outcomes
Sensitivity and Specificity of MRD Assay
Time frame: Assessed at specific landmarks (e.g., post-surgery and completion of adjuvant therapy) up to 48 months.
Overall Survival (OS)
Time frame: From the date of enrollment until the date of death from any cause, assessed up to 48 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 2 Feb 2026.
- Individual participant dataSharing planned: No
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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 Uterine Neoplasms and Cervical Cancer, run by Asan Medical Center 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 3 inclusion and 4 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 2 Feb 2026. 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 Jeong-Yeol Park, M.D., Ph.D. (+82-2-3010-3630, jypark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the date of enrollment until the date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 48 months.). 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 2 Feb 2026.