FibroidEFIBIANCT06576362
Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
A study testing Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy in people with Fibroid and Uterine Corpus Smooth Muscle Neoplasm, run by Assistance Publique Hopitaux De Marseille.
Trial summary
The goal of this diagnostic, prospective study is to evaluate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, in women aged 18 and more, and to evaluate complications relating to the the technique and its potential adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroid, Uterine Corpus Smooth Muscle Neoplasm
- What is being tested?
- Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age consulting at the hospital who require surgical management for uterine smooth muscle tumors (fibroma or TMM).
- Able to give written consent
- Beneficiary or beneficiary of a social security scheme
Who cannot join
- Person in a period of exclusion from another research protocol at the time consent is signed.
- Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code, i.e. :
- Pregnant women, parturients and nursing mothers
- Persons deprived of their liberty by judicial or administrative decision
- Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8.
- Minors
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- Adults subject to a legal protection measure or unable to express their consent.
- A person who does not have a sufficient command of the French language to be able to give consent to participate in research.
- Any other reason which, in the opinion of the investigator, could compromise the safety of the research participant and/or interfere with the evaluation of the research objectives.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
The goal of this diagnostic, prospective study is to evaluate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, in women aged 18 and more, and to evaluate complications relating to the the technique and its potential adverse events.
Participants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study.
Read more
Preoperatively, women will undergo the following two examinations:
- A pelvic MRI, the characteristics of which will be analyzed by the expert women\'s imaging team.
- A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy.
250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months
Read the detailed description
Fibroma is the most common uterine smooth muscle tumor. Women are symptomatic in 30% of cases. A large proportion of fibroids are asymptomatic and discovered on imaging. Surgical management is the only recommended first-line treatment option in cases of symptoms. Hysterectomy is the most radical treatment, but for women wishing to preserve their fertility, myomectomy is the most suitable option. This is performed by hysteroscopy, laparoscopy or laparotomy. The main risk of myomectomy is massive intraoperative haemorrhage, requiring blood transfusion or even a haemostasis hysterectomy. There are non-surgical alternatives using embolization and radiofrequency, but these techniques do not provide a definitive diagnosis of fibroids, as they do not involve histological sampling.
The benign uterine fibroma is part of the broader concept of uterine smooth muscle tumors, which also includes myometrial malignancies of varying malignancy (uterine sarcomas, cellular fibromas, STUMP (Uterine smooth muscle tumors of uncertain malignant potential)).
Magnetic resonance imaging (MRI) is the most effective examination for discriminating fibroids from TMM, but its reliability is limited. This leads to inappropriate management in a number of situations. The first is the risk of over-treatment by performing surgery for suspected TMM on MRI in a patient with few or no symptoms and a final histological diagnosis of fibroid. The second is the risk of unsatisfactory, even deleterious, carcinological surgical treatment in a symptomatic patient with a reassuring MRI diagnosis but a final histological diagnosis of TMM. The last situation is the possibility of treating a lesion labelled fibroid on MRI with an alternative technique (embolization, radiofrequency, HIFU) when it is in fact a TMM, thereby delaying appropriate management and worsening the prognosis.
Ultrasound-guided transuterine vaginal biopsy (ETVB) is an innovative and promising minimally invasive technique for preoperative anatomopathological diagnosis. It can be used to obtain a histological diagnosis, thus avoiding the need for surgery and the inappropriate treatment described above Primary objective: To validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy.
Secondary objectives Evaluate the complications associated with the technique, as well as its potential adverse effects.
Exploratory objectives: To assess the feasibility of the technique in routine practice.
Primary endpoint: Estimation of the anatomopathological sensitivity of BVTE, with its 95% confidence interval, by comparing it with the reference technique, i.e. anatomopathological diagnosis on surgical specimen, to ensure a low number of false negatives (fibroid diagnosis on BVTE with final diagnosis of TMM).
Secondary endpoints: Estimation of specificity, positive and negative predictive values and likelihood ratios of BVTE, with their confidence intervals, number of intraoperative and postoperative complications according to the Clavien-Dindo classification.
Exploratory criteria if applicable: Evaluation of equipment availability, cost, simplicity of performance as assessed by the operator.
- Conditions
- Fibroid, Uterine Corpus Smooth Muscle Neoplasm
- Being tested
- Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy
- Keywords
- TMM, BVTE, diagnosis, Vaginal biopsy, echo-guided transuterine vaginal biopsy, myomectomy, hysterectomy
- Medical subject headings
- Leiomyoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomyProcedure or surgery
Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Echoguided transuterine vaginal biopsy | Experimental | Echoguided transuterine vaginal biopsy on women presenting to hospital with a surgical indication for myomectomy or hysterectomy Receives: Procedure: Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy
Estimate the anatomopathological sensitivity of BVTE, with its 95% confidence interval, by comparing it with the reference technique, i.e. anatomopathological diagnosis on surgical specimens, to ensure a low number of false negatives (fibroid diagnosis on BVTE with final diagnosis of TMM)
Measured: From enrollment before surgery to the follow-up visit 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective diagnostic study vs. reference technique
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura MIQUEL, Dr, Principal investigator, Assistance Publique - Hôpitaux de marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576362
- Sponsor's protocol ID
- RCAPHM23-0387
- Other IDs
- 2024-A01337-40
- Acronym
- EFIBIA
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
- ClinicalTrials.gov ID
- NCT06576362
- Acronym / sponsor ID
- EFIBIA / RCAPHM23-0387
- Conditions
- Fibroid, Uterine Corpus Smooth Muscle Neoplasm
- Keywords
- TMM, BVTE, diagnosis, Vaginal biopsy, echo-guided transuterine vaginal biopsy, myomectomy, hysterectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this diagnostic, prospective study is to evaluate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, in women aged 18 and more, and to evaluate complications relating to the the technique and its potential adverse events.
Participants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study.
Preoperatively, women will undergo the following two examinations:
- A pelvic MRI, the characteristics of which will be analyzed by the expert women\'s imaging team.
- A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy.
250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months
Detailed description
Fibroma is the most common uterine smooth muscle tumor. Women are symptomatic in 30% of cases. A large proportion of fibroids are asymptomatic and discovered on imaging. Surgical management is the only recommended first-line treatment option in cases of symptoms. Hysterectomy is the most radical treatment, but for women wishing to preserve their fertility, myomectomy is the most suitable option. This is performed by hysteroscopy, laparoscopy or laparotomy. The main risk of myomectomy is massive intraoperative haemorrhage, requiring blood transfusion or even a haemostasis hysterectomy. There are non-surgical alternatives using embolization and radiofrequency, but these techniques do not provide a definitive diagnosis of fibroids, as they do not involve histological sampling.
The benign uterine fibroma is part of the broader concept of uterine smooth muscle tumors, which also includes myometrial malignancies of varying malignancy (uterine sarcomas, cellular fibromas, STUMP (Uterine smooth muscle tumors of uncertain malignant potential)).
Magnetic resonance imaging (MRI) is the most effective examination for discriminating fibroids from TMM, but its reliability is limited. This leads to inappropriate management in a number of situations. The first is the risk of over-treatment by performing surgery for suspected TMM on MRI in a patient with few or no symptoms and a final histological diagnosis of fibroid. The second is the risk of unsatisfactory, even deleterious, carcinological surgical treatment in a symptomatic patient with a reassuring MRI diagnosis but a final histological diagnosis of TMM. The last situation is the possibility of treating a lesion labelled fibroid on MRI with an alternative technique (embolization, radiofrequency, HIFU) when it is in fact a TMM, thereby delaying appropriate management and worsening the prognosis.
Ultrasound-guided transuterine vaginal biopsy (ETVB) is an innovative and promising minimally invasive technique for preoperative anatomopathological diagnosis. It can be used to obtain a histological diagnosis, thus avoiding the need for surgery and the inappropriate treatment described above Primary objective: To validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy.
Secondary objectives Evaluate the complications associated with the technique, as well as its potential adverse effects.
Exploratory objectives: To assess the feasibility of the technique in routine practice.
Primary endpoint: Estimation of the anatomopathological sensitivity of BVTE, with its 95% confidence interval, by comparing it with the reference technique, i.e. anatomopathological diagnosis on surgical specimen, to ensure a low number of false negatives (fibroid diagnosis on BVTE with final diagnosis of TMM).
Secondary endpoints: Estimation of specificity, positive and negative predictive values and likelihood ratios of BVTE, with their confidence intervals, number of intraoperative and postoperative complications according to the Clavien-Dindo classification.
Exploratory criteria if applicable: Evaluation of equipment availability, cost, simplicity of performance as assessed by the operator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective diagnostic study vs. reference technique
| Arm | Type | Receives |
|---|---|---|
| Echoguided transuterine vaginal biopsy | Experimental | Procedure: Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomyEchoguided transuterine vaginal biopsy on women presenting to hospital with a surgical indication for myomectomy or hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age consulting at the hospital who require surgical management for uterine smooth muscle tumors (fibroma or TMM).
- Able to give written consent
- Beneficiary or beneficiary of a social security scheme
Key exclusion criteria (9 listed)
- Person in a period of exclusion from another research protocol at the time consent is signed.
- Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code, i.e. :
- A person who does not have a sufficient command of the French language to be able to give consent to participate in research.
- Any other reason which, in the opinion of the investigator, could compromise the safety of the research participant and/or interfere with the evaluation of the research objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomyEchoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy | Procedure or surgery | Echoguided transuterine vaginal biopsy |
Primary outcome
Validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy
Time frame: From enrollment before surgery to the follow-up visit 3 months after surgery
Estimate the anatomopathological sensitivity of BVTE, with its 95% confidence interval, by comparing it with the reference technique, i.e. anatomopathological diagnosis on surgical specimens, to ensure a low number of false negatives (fibroid diagnosis on BVTE with final diagnosis of TMM)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura MIQUEL, Dr principal investigator
Assistance Publique - Hôpitaux de marseille
Questions about this trial
What is this clinical trial studying?
A study testing Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy in people with Fibroid and Uterine Corpus Smooth Muscle Neoplasm, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Miquel, Dr (0491382747, laura.miquel@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy (time frame: From enrollment before surgery to the follow-up visit 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.