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Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cervical Cancer

NCT07382505NOT_YET_RECRUITINGOBSERVATIONAL

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. 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.

Key Facts

Lead Sponsor

Asan Medical Center

Enrollment

600

Start Date

2026-02-15

Completion Date

2027-06-30

Study Type

OBSERVATIONAL

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

Interventions

Serial blood collection for MRD testing

Conditions

Uterine NeoplasmsCervical Cancer

Eligibility

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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.

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 Outcomes

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.

Time frame: 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).

Time frame: From the date of enrollment until the date of death from any cause, assessed up to 48 months.

Locations

Asan Medical Center, Seoul, South Korea

Linked Diseases

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.