Active not recruitingNAINTERVENTIONAL

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

This study aims to find out how accurate a special type of scan-guided biopsy is at identifying whether a uterine growth is a harmless fibroid or a more serious type called a sarcoma. This information is really important because it helps doctors choose the safest and most effective surgery. If a growth is a sarcoma, a different surgical approach is often needed to remove it completely without spreading any cells. This study involves women aged 35 and older who have a suspicious growth in their womb and are being considered for surgery. It is taking place across ten hospitals in France, and the main goal is to improve how doctors diagnose these conditions before surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Institut Bergonié

Enrolment target

Start

07 Sep 2021

Estimated completion

01 Dec 2027

Fibroid Uterus Sarcoma Uterus

What is this study about?

Imagine you have a growth in your womb (uterus). Often, these are harmless growths called fibroids. However, sometimes they can be a more serious type called a sarcoma. Telling the difference before surgery is really important because it helps doctors plan the best way to remove it to keep you as safe as possible and get the best health outcome.

This study is looking at a specific way to check these growths: a special biopsy guided by an ultrasound scan through the vagina. The doctors want to see how good this biopsy is at accurately identifying whether a growth is a fibroid or a sarcoma. This matters because if a growth is a sarcoma, doctors usually need to remove the womb (a hysterectomy) in one piece, without breaking the growth into smaller pieces, to prevent any cancer cells from spreading. For fibroids, sometimes less invasive keyhole surgery (laparoscopy) can be an option, which might involve breaking the fibroid into smaller pieces inside the body before removal, a process called morcellation.

By getting a clear diagnosis before surgery, doctors can make better decisions about which surgical method is safest and most effective for each individual. This study hopes to improve how doctors manage these suspicious uterine growths, making sure patients get the most appropriate care right from the start. All participants will have their womb removed through a traditional open surgery without breaking up the growth, regardless of the biopsy result, to ensure safety while comparing the biopsy results to the final surgical findings.

Key takeaways

The study helps doctors tell if a womb growth is harmless or cancerous before surgery.
It uses a special scan-guided biopsy through the vagina.
This helps decide the safest way to remove the growth.
Participants will have standard open surgery to remove their womb.
It aims to improve diagnosis for future patients with similar conditions.

Who may be eligible?

To join this study, you would need to be a woman aged 35 or older with a suspicious growth in your womb that doctors are considering removing with surgery. Your growth would be considered suspicious if it's growing quickly (at least 30% bigger in a year), or if you're past menopause and experiencing bleeding, pain, or other symptoms. Also, if ultrasound scans show certain features like a large size (over 8 cm), unusual blood flow, or specific internal formations, it might qualify.

You would also need to have had an MRI scan of your pelvis done recently (within 30 days before the biopsy) and the growth must be in a position that allows the doctor to take a biopsy using a special scan-guided method directly through the vagina. You must be well enough for open surgery (laparotomy) and be able to give your informed consent. Importantly, you must not be pregnant or breastfeeding, or planning to become pregnant, and must not have any other medical conditions that would make the biopsy or surgery unsafe, such as serious bleeding problems or previous cancer treatment in the last two years.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 35 or older?
Do you have a suspicious growth in your womb that doctors are considering for surgery?
Have you had an MRI scan of your pelvis recently (within the last 30 days)?
Is your growth in a position that can be reached by a biopsy through the vagina?
Are you not pregnant or breastfeeding, and not planning a pregnancy soon?
Do you not have any other serious health issues that would make the biopsy or surgery unsafe?

Answer every question to see your result.

What does participation involve?

If you decide to take part, first you'll have a meeting to understand the study fully and give your written consent. Within 30 days before the biopsy, you'll have some check-ups including a physical exam, a gynaecological exam, and blood and imaging tests (Doppler ultrasound and MRI).

Next, you'll have the echo-guided biopsy. This involves a specialist doctor using a scan to guide a small needle through the vagina to take a sample of the growth. You'll have local anaesthetic to numb the area, and they'll ask about any pain during the procedure. After the biopsy, your surgeon will review the results and check for any pain or problems.

Then, you'll have surgery where your womb will be removed (a hysterectomy) through an open surgery (laparotomy) without breaking up the growth. The surgeon will also carefully examine your abdominal and pelvic areas during the operation. About a month after your surgery, you'll have a follow-up visit with your surgeon to check on your recovery and discuss the final results. After this, your care will continue as normal based on what the tests show.

Potential risks and benefits

This study aims to improve how doctors diagnose womb growths, which could lead to better surgical planning for patients in the future. While there are no direct new medical benefits for participants beyond receiving standard care, your participation will help advance medical knowledge. Potential risks include discomfort or minor complications from the biopsy, such as bleeding or infection, and the usual risks associated with general anaesthesia and major surgery. You are free to withdraw from the study at any time without explaining why, and this will not affect your medical care.

Locations (1)

Institut Bergonié
Verified postcode
Bordeaux, France

Common questions

What is morcellation?

Morcellation is a technique sometimes used in keyhole surgery where a growth, like a fibroid, is cut into smaller pieces to remove it through a small incision. This study is trying to find out if growths are not cancerous before using this method.

What is an echo-guided uterine biopsy?

This is a procedure where a doctor uses an ultrasound scan to see inside your womb and guide a very thin needle to take a small sample of the growth. This sample is then checked in a lab.

Will I have open surgery or keyhole surgery in this study?

All participants in this study will have open surgery (laparotomy) to remove their womb, and the growth will be removed in one piece without breaking it up. This is done to ensure safety and allow for comparison with the biopsy results.

What's the difference between a fibroid and a sarcoma?

A fibroid is a very common, non-cancerous growth in the womb. A sarcoma is a rare, cancerous growth. Distinguishing between them before surgery is crucial for planning the safest treatment.

Will I receive special treatment if I join this study?

Your medical care will follow standard procedures, but your participation helps doctors learn more about diagnosing these conditions, which could benefit future patients. You won't receive different medical treatment than you would otherwise, but you'll help advance medical knowledge.