Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)
Condition(s) studied
Investigational drug(s) / intervention(s)
Echo-guided uterine biopsy: Echo-guided uterine biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. 4 to 5 samples will be made. Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale).
Study summary
This is a prospective multi-center interventional study that will be performed in an effort to assess the diagnostic accuracy performance of preoperative vaginal ultrasound-guided biopsy (VUGB) to detect the exact histology of uterine tumors and thereafter triage cases being eligible for morcellation during laparoscopic resection. Ten tertiary French centers will participate in the present study.
Eligibility
Primary outcome measure(s)
- Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors. — After surgery, an average of 2 months after inclusion
Sensitivity is the proportion of patients with malignant/STUMP result on the local reading of biopsy (index test) divided by the number of patients with malignant/STUMP result on the local reading of surgical specimen (reference standard). Primary outcome assessment will be based on the local reading.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Bergonié | Bordeaux | France |
More Institut Bergonié trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04250766 on ClinicalTrials.gov ↗ ← All trials in France