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Detection of Tumor DNA Through Cervical Smear and Liquid Biopsy in Endometrial Cancer Patients and Evaluation of Prognostic and Predictive Values of Tumor DNA Assay

NCT05504161 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-08-17

No results posted yet for this study

Summary

Circulating tumor DNA (ctDNA) may help detect and prognosis-stratify patients with endometrial cancer. Both cervical swab-based genomic DNA (gDNA) and whole blood-based ctDNA can be utilized for this goal. Our objective is to utilize cervical swab and whole blood samples to analyze tumor-derived ctDNA from patients with endometrial cancer. These samples will be collected prospectively, and prior to staging operation. Samples from patients without cancer, who undergo hysterectomy for benign gynecological cause, will be utilized as controls. Variants called by next generation sequencing were classified into four-tiers based on ASCO/AMP system. These initially captured samples will be used to compare performance in terms of detection rate and to stratify patients based on the mutational profile. Additionally, in patients with advanced disease, we plan to collect whole blood samples every 3 months to assess any changes in mutational landscape. Clinical data including age, cormorbidities, treatment methods, date of diagnosis and recurrence, response evaluation for chemotherapy or radiotherapy, survival data will be used to contextualize our findings.

Conditions

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Jung-Yun Lee, M.D. · Department of Obstetrics and Gynecology, Yonsei University College of Medicine

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05504161 on ClinicalTrials.gov