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 | Unknown

• 1 other identifier: 4-2020-1265
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Endometrial cancer group

Patients pathologically diagnosed with endometrial cancer

Control group

Patients with benign endometrial pathology and interepithelial neoplasia

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed endometrial cancer (case) and benign gynecological disease (control)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor genomic DNA from cervical swab and cell-free DNA from frozen plasma

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jung-Yun Lee, M.D.

  Department of Obstetrics and Gynecology, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Yun Lee, M.D.

CONTACT

+82 2 2228 2760; jungyunlee@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: December 30, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)