Clinical trial · Observational
Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cervical Cancer
Prospective Cohort to Evaluate the Prognostic and Early-Recurrence Detection Performance of Blood-based Minimal Residual Disease (MRD) Testing in Endometrial and Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serial blood collection for MRD testing | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- endometrial cancer cohort
- description
- patients diagnosed with endometrial cancer
- interventionNames
- Genetic: Serial blood collection for MRD testing
- label
- cervical cancer cohort
- description
- patients diagnosed with cervical cancer
- interventionNames
- Genetic: Serial blood collection for MRD testing
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available