Skip to main content
Clinical Trials/NCT05504161
NCT05504161
Unknown
Not Applicable

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

Yonsei University1 site in 1 country300 target enrollmentDecember 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrial Cancer
Sponsor
Yonsei University
Enrollment
300
Locations
1
Primary Endpoint
Detection rate
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 30, 2020
End Date
December 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female, over 19 years of age
  • Patients with endometrial cancer or benign gynecological diseases

Exclusion Criteria

  • Patients in pregnancy
  • Patients being treated for cancer of other organs, including gynecological cancer.
  • Patients who has difficulty reading and understanding Korean.
  • The tester's determination that the patient will not be able to comply with the clinical trial procedures.
  • Patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.

Outcomes

Primary Outcomes

Detection rate

Time Frame: Detection rate based on two different modalities at the time of surgery.

We aim to compare the ctDNA mutation detection rate based on cervical swab and whole blood at the time of surgery.

Study Sites (1)

Loading locations...

Similar Trials