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Trial Title:
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
NCT ID:
NCT05504161
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients who are diagnosed endometrial cancer (case) and benign gynecological disease
(control)
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Female, over 19 years of age
2. Patients with endometrial cancer or benign gynecological diseases
Exclusion Criteria:
1. Patients in pregnancy
2. Patients being treated for cancer of other organs, including gynecological cancer.
3. Patients who has difficulty reading and understanding Korean.
4. The tester's determination that the patient will not be able to comply with the
clinical trial procedures.
5. 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.
Gender:
Female
Minimum age:
19 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yonsei University Health System, Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jung-Yun LEE
Phone:
+82 2 2228 2760
Email:
jungyunlee@yuhs.ac
Start date:
December 30, 2020
Completion date:
December 2023
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504161
