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
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|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
Endometrial cancer group
Patients pathologically diagnosed with endometrial cancer
Patients with benign endometrial pathology and interepithelial neoplasia
- 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
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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|
- Female, over 19 years of age
- Patients with endometrial cancer or benign gynecological diseases
- 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.
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
|Contact: Jung-Yun Lee, M.D.||+82 2 2228 firstname.lastname@example.org|
|Korea, Republic of|
|Yonsei University Health System, Severance Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Jung-Yun LEE +82 2 2228 2760 email@example.com|
|Principal Investigator:||Jung-Yun Lee, M.D.||Department of Obstetrics and Gynecology, Yonsei University College of Medicine|
|Responsible Party:||Yonsei University|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Genital Neoplasms, Female
Neoplasms by Site