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

NCT07382505 | Not Yet Recruiting

• 1 other identifier: Seoul Asan Medical Center
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Neoplasms; Cervical Cancer

Keywords

Endometrial Cancer; Cervical Cancer; Minimal Residual Disease; MRD; Circulating Tumor DNA; Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Assessed at specific landmarks (e.g., post-surgery and completion of adjuvant therapy) up to 48 months.

• Overall Survival (OS)

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

Study Arms (2)

endometrial cancer cohort

patients diagnosed with endometrial cancer

Genetic: Serial blood collection for MRD testing

cervical cancer cohort

patients diagnosed with cervical cancer

Genetic: Serial blood collection for MRD testing

Interventions

Serial blood collection for MRD testing GENETIC

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.

cervical cancer cohort; endometrial cancer cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

The study will collect and retain the following biospecimens for the evaluation of Minimal Residual Disease (MRD) and genomic profiling: Whole Blood (20 mL): Collected at multiple time points (diagnosis, post-surgery, post-adjuvant therapy, and every 3 months during follow-up). Tumor Tissue: Formalin-Fixed Paraffin-Embedded (FFPE) blocks or slides from diagnostic biopsies or surgical specimens.

MeSH Terms

Conditions

Uterine Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jeong-Yeol Park, M.D., Ph.D.

CONTACT

+82-2-3010-3630; jypark@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 2, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)