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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometrial cancer group | Patients pathologically diagnosed with endometrial cancer | ||
| Control group | Patients with benign endometrial pathology and interepithelial neoplasia |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are diagnosed endometrial cancer (case) and benign gynecological disease (control)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Yun Lee, M.D. | Contact | +82 2 2228 2760 | jungyunlee@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Jung-Yun Lee, M.D. | Department of Obstetrics and Gynecology, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
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tumor genomic DNA from cervical swab and cell-free DNA from frozen plasma
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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