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

NCT04250766 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-10-02

No results posted yet for this 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.

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).

Sponsors & Collaborators

  • GIRCI SOHO

    collaborator OTHER

  • Institut Bergonié

    lead OTHER

Principal Investigators

  • Frédéric GUYON, Dr · Institut Bergonié

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2026-06-30
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250766 on ClinicalTrials.gov