Fibroid UterusBIOPSARNCT04250766
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)
A study testing Echo-guided uterine biopsy in people with Fibroid Uterus and Sarcoma Uterus, run by Institut Bergonié at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Fibroid Uterus, Sarcoma Uterus
- What is being tested?
- Echo-guided uterine biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2021to Dec 2027
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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".
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- 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.
Who cannot join
- General contraindication(s) to performing a transvaginal echo-guided biopsy.
- Biopsy by peritoneal approach (surgical or percutaneous).
- History of treated cancer in the two years preceding inclusion or in progressive continuation.
- Unfavorable anesthetic assessment that does not allow general anesthesia for the planned surgery.
- Coagulation disorders contraindicating biopsy.
- Pregnancy project.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors
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.
Read the detailed description
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.
During the inclusion check-up, exams must be performed within 30 days before the guided echo biopsy: clinical examination, gynecological examination, pain assessment (visual or verbal scale), biological and radiological assessment (Doppler ultrasound Pelvis and MRI pelvis).
The echo-guided biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale).
Between the biopsy and the procedure, the patient will be reviewed by the investigating surgeon to check the outcome of the biopsy, any pain or complications of the biopsy.
The surgical procedure will be performed by laparotomy and will consist of an extra-facial hysterectomy without fragmentation of the surgical specimen (extraction technique "in block"). During the procedure, the investigating surgeon will perform a description of the abdominal and pelvic cavity and perform a block excision of the tumor.
At one month of the surgery, patient will be reviewed by the investigating surgeon for a postoperative visit with clinical examination, gynecological and histopathological results.
Thereafter, the follow-up of the patients will be carried out according to the standards of care according to the histopathological results.
- Conditions
- Fibroid Uterus, Sarcoma Uterus
- Being tested
- Echo-guided uterine biopsy
- Keywords
- Uterine fibroma, Suspect uterine sarcoma, Echo-guided biopsy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-guided uterine biopsyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Single arm echo-guided uterine biopsy | Other | Not described Receives: Procedure: Echo-guided uterine biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Specificity is the proportion of patients with benign result on the local reading of biopsy divided by the number of patients with benign result on the local reading of surgical specimen.
Measured: After surgery, an average of 2 months after inclusion
Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives). Assessment will be based on the local reading.
Measured: After surgery, an average of 2 months after inclusion
Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value. Assessment will be based on the local reading.
Measured: After surgery, an average of 2 months after inclusion
Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
PPV is the proportion of patients with malignant/STUMP results on the local reading of biopsy and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).
Measured: After surgery, an average of 2 months after inclusion
Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
NPV is the proportion of patients with benign results on the local reading of biopsy and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives)
Measured: After surgery, an average of 2 months after inclusion
Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Sensitivity is the proportion of patients with malignant/STUMP result on the centralized review of biopsy (index test) divided by the number of patients with malignant/STUMP result on the centralized review of surgical specimen (reference standard).
Measured: After surgery, an average of 2 months after inclusion
Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Specificity is the proportion of patients with benign result on the centralized review of biopsy divided by the number of patients with benign result on the centralized review of surgical specimen.
Measured: After surgery, an average of 2 months after inclusion
Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives). Assessment will be based on the centralized review by an expert pathologist.
Measured: After surgery, an average of 2 months after inclusion
Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value. Assessment will be based on the centralized review by an expert pathologist.
Measured: After surgery, an average of 2 months after inclusion
Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
PPV is the proportion of patients with malignant/STUMP results on the centralized review of biopsy and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).
Measured: After surgery, an average of 2 months after inclusion
Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
NPV is the proportion of patients with benign results on centralized review of biopsy and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives).
Measured: After surgery, an average of 2 months after inclusion
Sensitivity (Se) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Sensitivity is the proportion of patients with malignant/STUMP result on imaging divided by the number of patients with malignant/STUMP result on the local reading of surgical specimen (reference standard).
Measured: After surgery, an average of 2 months after inclusion
Specificity (Sp) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Specificity is the proportion of patients with benign result on imaging divided by the number of patients with benign result on the local reading of surgical specimen.
Measured: After surgery, an average of 2 months after inclusion
Accuracy of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives).
Measured: After surgery, an average of 2 months after inclusion
Youden's index (J) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value.
Measured: After surgery, an average of 2 months after inclusion
Positive Predictive Value (PPV) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
PPV is the proportion of patients with malignant/STUMP results on imaging and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).
Measured: After surgery, an average of 2 months after inclusion
Negative Predictive Value (NPV) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
NPV is the proportion of patients with benign results on Imaging and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives)
Measured: After surgery, an average of 2 months after inclusion
Reproducibility of local histopathological reading and centralized review by an expert pathologist of the echo-guided uterine biopsies.
Cohen's Kappa coefficient. kappa coefficient values greater than 0.75 correspond to acceptable reproducibility.
Measured: After surgery, an average of 2 months after inclusion
Change From Baseline in Pain Scores on the Visual Analog Scale after biopsy.
The minimum value is 0 and the maximum value is 10. A high score of pain indicates a high level of pain.
Measured: at inclusion and after surgery (2 months after inclusion)
Number of complications as assessed by the classification of Clavien-Dindo
Complications related to biopsy will be evaluated after biopsy.
Measured: After biopsy, an average of 1 day after inclusion.
Number of adverse events as assessed by CTCAE v5.0
Adverse events will be evaluated at inclusion, on the day of the biopsy and after the biopsy.
Measured: an average of 2 months after inclusion
Progression-free survival (PFS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).
PFS is defined as the time interval between the date of surgery and the date of progression and/or death whichever occurs first
Measured: After surgery, an average of 3 years after surgery
Overall survival (OS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).
OS is defined as the time interval between the date of surgery and the date of death (of any cause).
Measured: After surgery, an average of 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start7 Sep 2021
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI SOHO
- Responsible party
- Sponsor
- Investigators
- Frédéric GUYON, Dr, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250766
- Sponsor's protocol ID
- IB 2018-02
- Other IDs
- 2018-A02343-52
- Acronym
- BIOPSAR
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2019
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors
- ClinicalTrials.gov ID
- NCT04250766
- Acronym / sponsor ID
- BIOPSAR / IB 2018-02
- Conditions
- Fibroid Uterus, Sarcoma Uterus
- Keywords
- Uterine fibroma, Suspect uterine sarcoma, Echo-guided biopsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- GIRCI SOHO
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Jan 2020 (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.
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.
Detailed description
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.
During the inclusion check-up, exams must be performed within 30 days before the guided echo biopsy: clinical examination, gynecological examination, pain assessment (visual or verbal scale), biological and radiological assessment (Doppler ultrasound Pelvis and MRI pelvis).
The echo-guided biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale).
Between the biopsy and the procedure, the patient will be reviewed by the investigating surgeon to check the outcome of the biopsy, any pain or complications of the biopsy.
The surgical procedure will be performed by laparotomy and will consist of an extra-facial hysterectomy without fragmentation of the surgical specimen (extraction technique "in block"). During the procedure, the investigating surgeon will perform a description of the abdominal and pelvic cavity and perform a block excision of the tumor.
At one month of the surgery, patient will be reviewed by the investigating surgeon for a postoperative visit with clinical examination, gynecological and histopathological results.
Thereafter, the follow-up of the patients will be carried out according to the standards of care according to the histopathological results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm echo-guided uterine biopsy | Other | Procedure: Echo-guided uterine biopsy |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- General contraindication(s) to performing a transvaginal echo-guided biopsy.
- Biopsy by peritoneal approach (surgical or percutaneous).
- History of treated cancer in the two years preceding inclusion or in progressive continuation.
- Unfavorable anesthetic assessment that does not allow general anesthesia for the planned surgery.
- Coagulation disorders contraindicating biopsy.
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 |
|---|---|---|
| Echo-guided uterine biopsyEcho-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). | Procedure or surgery | Single arm echo-guided uterine biopsy |
Primary outcome
Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
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.
23 secondary outcomes
Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Time frame: After surgery, an average of 2 months after inclusion
Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Time frame: After surgery, an average of 2 months after inclusion
Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Time frame: After surgery, an average of 2 months after inclusion
Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Time frame: After surgery, an average of 2 months after inclusion
Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Time frame: After surgery, an average of 2 months after inclusion
Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Time frame: After surgery, an average of 2 months after inclusion
Sensitivity (Se) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Specificity (Sp) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Accuracy of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Youden's index (J) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Positive Predictive Value (PPV) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Negative Predictive Value (NPV) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Time frame: After surgery, an average of 2 months after inclusion
Reproducibility of local histopathological reading and centralized review by an expert pathologist of the echo-guided uterine biopsies.
Time frame: After surgery, an average of 2 months after inclusion
Change From Baseline in Pain Scores on the Visual Analog Scale after biopsy.
Time frame: at inclusion and after surgery (2 months after inclusion)
Number of complications as assessed by the classification of Clavien-Dindo
Time frame: After biopsy, an average of 1 day after inclusion.
Number of adverse events as assessed by CTCAE v5.0
Time frame: an average of 2 months after inclusion
Progression-free survival (PFS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).
Time frame: After surgery, an average of 3 years after surgery
Overall survival (OS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).
Time frame: After surgery, an average of 3 years after surgery
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 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Frédéric GUYON, Dr principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echo-guided uterine biopsy in people with Fibroid Uterus and Sarcoma Uterus, run by Institut Bergonié at 1 site in France.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors. (time frame: After surgery, an average of 2 months after inclusion). 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 2 Oct 2025.