NCT04250766Active, not recruiting
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 15 Nov 2019
- Start date
- 7 Sept 2021
- Primary completion date
- Jun 2026
- Lead sponsor
- Institut Bergonié
- Diseases
- Sarcoma
- NCT number
- NCT04250766
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 7 Sept 2021 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Biopsy by peritoneal approach (surgical or percutaneous).
- Unfavorable anesthetic assessment that does not allow general anesthesia for the planned surgery.
Other illness
- History of treated cancer in the two years preceding inclusion or in progressive continuation.
- Coagulation disorders contraindicating biopsy.
Other
- General contraindication(s) to performing a transvaginal echo-guided biopsy.
- Pregnancy project.
- Pregnant or lactating woman.
- Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons.
- Patient deprived of liberty under legal protection measure or unable to express her consent.
Who the study is looking for
- Woman \>= 35 years old
- 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:
- Rapid tumor growth defined as ≥30% of the maximum diameter in 1-year interval based on imaging findings, or,
- 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,
- 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.
- Genetical predisposal to cancer syndromes such as Lynch syndrome, hereditary leiomyomatosis or "renal cell cancer".
- MRI performed according to the technical and interpretation criteria stipulated in the study within 30 days before the biopsy.
- Uterine fibroma accessible to transvaginal echo-guided biopsy exclusively.
- No contraindication to performing laparotomy surgery.
- Voluntary signed written informed consent.
- Patient with a social security in compliance with the French law.
Age in the registry: 35 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.