The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05504161
Recruitment Status : Recruiting
First Posted : August 17, 2022
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date August 15, 2022
First Posted Date August 17, 2022
Last Update Posted Date August 17, 2022
Actual Study Start Date December 30, 2020
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2022)		 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
tumor genomic DNA from cervical swab and cell-free DNA from frozen plasma
Sampling Method Non-Probability Sample
Study Population Patients who are diagnosed endometrial cancer (case) and benign gynecological disease (control)
Condition Endometrial Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Endometrial cancer group
    Patients pathologically diagnosed with endometrial cancer
  • Control group
    Patients with benign endometrial pathology and interepithelial neoplasia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 15, 2022)		 300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jung-Yun Lee, M.D. +82 2 2228 2760 jungyunlee@yuhs.ac
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT05504161
Other Study ID Numbers 4-2020-1265
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Yonsei University
Original Responsible Party Same as current
Current Study Sponsor Yonsei University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Jung-Yun Lee, M.D. Department of Obstetrics and Gynecology, Yonsei University College of Medicine
PRS Account Yonsei University
Verification Date August 2022