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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

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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

Study Description
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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.

Condition or disease
Endometrial Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort
Endometrial cancer group
Patients pathologically diagnosed with endometrial cancer
Control group
Patients with benign endometrial pathology and interepithelial neoplasia


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
tumor genomic DNA from cervical swab and cell-free DNA from frozen plasma

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are diagnosed endometrial cancer (case) and benign gynecological disease (control)
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05504161


Contacts
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Contact: Jung-Yun Lee, M.D. +82 2 2228 2760 jungyunlee@yuhs.ac

Locations
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Korea, Republic of
Yonsei University Health System, Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jung-Yun LEE    +82 2 2228 2760    jungyunlee@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Jung-Yun Lee, M.D. Department of Obstetrics and Gynecology, Yonsei University College of Medicine
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT05504161    
Other Study ID Numbers: 4-2020-1265
First Posted: August 17, 2022    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases