Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serial blood collection for MRD testing.
- Who it may be relevant to
- Registry conditions: Uterine Neoplasms, Cervical Cancer. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Genetic Serial blood collection for MRD testing
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 blo
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- 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.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Asan Medical Center — Seoul
Identifiers
NCT: NCT07382505 · Seoul Asan Medical Center