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ACTIVE NOT RECRUITING

NCT04250766

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

Sponsor: Institut Bergonié

View on ClinicalTrials.gov

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.

Official title: Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors

Key Details

Gender

FEMALE

Age Range

35 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-09-07

Completion Date

2027-12

Last Updated

2025-10-02

Healthy Volunteers

Conditions

Fibroid Uterus Sarcoma Uterus

Interventions

PROCEDURE

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).

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.

Locations (1)

Institut Bergonié

Bordeaux, France