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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05504161

Enrollment

300

Registered

2022-08-17

Start date

2020-12-30

Completion date

2023-12-31

Last updated

2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Detection rate	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.

Countries

South Korea

Contacts

Primary ContactJung-Yun Lee, M.D.

jungyunlee@yuhs.ac+82 2 2228 2760

Outcome results