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New Ultrasound-Guided biopsy could prevent dangerous surgery for uterine tumors

NCT ID NCT04250766

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a special biopsy done with ultrasound guidance before surgery can correctly tell if a uterine tumor is cancerous or not. It involves 19 women aged 35 and older who have suspicious uterine tumors. The goal is to avoid risky surgical procedures if the tumor is benign.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

19 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institut Bergonié

    Bordeaux, 33076, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.