Clinical trial NCT04250766: Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)
Official title: Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibroid Uterus
Sarcoma Uterus
Keywords: Uterine fibroma
Suspect uterine sarcoma
Echo-guided biopsy
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: GIRCI SOHO
First posted: 2020-01-31
Enrollment: 19
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
Secondary outcomes:
measure: Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: 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.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Sensitivity (Se) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Specificity (Sp) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Accuracy of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Youden's index (J) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Positive Predictive Value (PPV) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Negative Predictive Value (NPV) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Reproducibility of local histopathological reading and centralized review by an expert pathologist of the echo-guided uterine biopsies.
timeFrame: After surgery, an average of 2 months after inclusion
measure: Change From Baseline in Pain Scores on the Visual Analog Scale after biopsy.
timeFrame: at inclusion and after surgery (2 months after inclusion)
measure: Number of complications as assessed by the classification of Clavien-Dindo
timeFrame: After biopsy, an average of 1 day after inclusion.
measure: Number of adverse events as assessed by CTCAE v5.0
timeFrame: an average of 2 months after inclusion
measure: Progression-free survival (PFS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).
timeFrame: After surgery, an average of 3 years after surgery
measure: Overall survival (OS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).
timeFrame: After surgery, an average of 3 years after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
Study officials:
affiliation: Institut Bergonié
name: Frédéric GUYON, Dr
role: PRINCIPAL_INVESTIGATOR
References: