Status:
NOT_YET_RECRUITING
The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions
Lead Sponsor:
Charles University, Czech Republic
Conditions:
Leiomyosarcoma
Eligibility:
FEMALE
18-80 years
Brief Summary
The Tru-cut biopsy (TCB) for targeting pelvic tumors is well established in gynecologic oncology. However, its reliability for differentiating of uterine sarcoma in "myoma-like" uterine lesions has be...
Detailed Description
A total of 250 patients is planned to be enrolled, accounting for an estimated 15% dropout rate. Study data will be collected and managed using REDCap (Research Electronic Data Capture) open-source pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06521060
Start Date
October 1 2024
End Date
June 1 2028
Last Update
July 25 2024
Active Locations (1)
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1
General hospital
Prague, Czechia, 12800