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

Endometrial Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504161
• Other study ID #: 4-2020-1265
• Status: Recruiting
• Start date: December 30, 2020
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Yonsei University
• Contact: Jung-Yun Lee, M.D.
• Phone: +82 2 2228 2760
• Email: jungyunlee[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate	We aim to compare the ctDNA mutation detection rate based on cervical swab and whole blood at the time of surgery.	Detection rate based on two different modalities at the time of surgery.