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

NCT04250766 | Active Not Recruiting

• 2 other identifiers: IB 2018-022018-A02343-52
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibroid Uterus; Sarcoma Uterus

Keywords

Uterine fibroma; Suspect uterine sarcoma; Echo-guided biopsy

Outcome Measures

Primary Outcomes (1)

• Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors.

  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.

  After surgery, an average of 2 months after inclusion

Secondary Outcomes (23)

• Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.

  After surgery, an average of 2 months after inclusion

• Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.

  After surgery, an average of 2 months after inclusion

• Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.

  After surgery, an average of 2 months after inclusion

• Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.

  After surgery, an average of 2 months after inclusion

• Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.

  After surgery, an average of 2 months after inclusion

Study Arms (1)

Single arm echo-guided uterine biopsy

OTHER

Procedure: Echo-guided uterine biopsy

Interventions

Echo-guided uterine biopsy PROCEDURE

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).

Single arm echo-guided uterine biopsy

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• General contraindication(s) to performing a transvaginal echo-guided biopsy.
• Biopsy by peritoneal approach (surgical or percutaneous).
• Unfavorable anesthetic assessment that does not allow general anesthesia for the planned surgery.
• Coagulation disorders contraindicating 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.

Sponsors & Collaborators

• Institut Bergonié: lead
• GIRCI SOHO: collaborator

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Frédéric GUYON, Dr

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: January 31, 2020
• Study Start: September 7, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

FR (1)