Ireland
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Active, not recruiting Not applicable

Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)

NCT04250766 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-09-07
Last updated
2025-10-02

Condition(s) studied

Fibroid UterusSarcoma Uterus

Investigational drug(s) / intervention(s)

Echo-guided uterine biopsy

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

Sex
FEMALE
Min age
35 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Woman \>= 35 years old 2. Diagnosis of suspicious uterine tumor involving surgical management by laparoscopic hysterectomy with possible morcellation. Fibroma must be considered suspect, if at least one of the following characteristics is fulfilled: 1. Rapid tumor growth defined as ≥30% of the maximum diameter in 1-year interval based on imaging findings, or, 2. Symptomatic tumors in postmenopausal women presenting vaginal bleeding or pelvic pain or palpable masses or symptoms caused by pressure of neighbor organs such as dysuria and gastrointestinal symptoms, or, 3. Tumors characterized by certain suspicious ultrasound criteria such as size \> 8 cm, presence and distribution of vascularization, presence of intratumoral lesions, ultrasound heterogeneity, necrosis, cystic components, presence of calcification. 4. Genetical predisposal to cancer syndromes such as Lynch syndrome, hereditary leiomyomatosis or "renal cell cancer". 3. MRI performed according to the technical and interpretation criteria stipulated in the study within 30 days before the biopsy. 4. Uterine fibroma accessible to transvaginal echo-guided biopsy exclusively. 5. No contraindication to performing laparotomy surgery. 6. Voluntary signed written informed consent. 7. Patient with a social security in compliance with the French law. Exclusion Criteria: 1. General contraindication(s) to performing a transvaginal echo-guided biopsy. 2. Biopsy by peritoneal approach (surgical or percutaneous). 3. History of treated cancer in the two years preceding inclusion or in progressive continuation. 4. Unfavorable anesthetic assessment that does not allow general anesthesia for the planned surgery. 5. Coagulation disorders contraindicating biopsy. 6. Pregnancy project. 7. Pregnant or lactating woman. 8. Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons. 9. Patient deprived of liberty under legal protection measure or unable to express her consent.

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)

FacilityCityRegionStatus
Institut Bergonié Bordeaux France
Official registry record

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