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Opening soonAges 18 Years to 80 Years

The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions

Sponsor: Charles University, Czech Republic · NCT06521060 on ClinicalTrials.gov ↗

Conditions studied

Leiomyosarcoma

What it tests

  • tru cut biopsyprocedure

Where it's running1 site

1 international site
  • General hospital

    Prague, Czechia 12800

See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years
* Women indicated for uterus-preserving surgery (tumour resection) or hysterectomy for myometrial lesion ('myoma-like' uterine tumour(s))
* USG finding of atypical myometrial lesion/s a

Exclusion Criteria:

patient 's refusal

* age \< 18 years
* ongoing pregnancy
* inability to perform TCB /contraindications for TCB (trombocytopenia, coagulopathy, PID, colpitis) or definitive surgery (myomectomy or hysterectomy)
* USG finding of more than 2 atypical lesion/s with a diameter ≤ 20 mm and ≥ 100 mm
* inability to perform any of the 3 core needle biopsy approaches (transvervical, trans uterine cavity, transvaginal) because of anatomical, localization issues. The percutaneous transabdominal biopsy is not allowed
* Polymyomatous uterus that may not be examined adequately with routine transvaginal ultrasound
* myoma (which would be subject to TCB) type 7 according to FIGO classification 16
* history of conservative hormonal therapy less than 3 months prior to study enrolment
* history of conservative therapy via uterine artery embolisation or laparoscopic uterine artery occlusion
* history of pregnancy less than one year prior to study enrollment

Updated 2024-07-25 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.