Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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".
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors.
时间窗: 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.
次要结局
- Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.(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.(After surgery, an average of 2 months after inclusion)
- Progression-free survival (PFS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).(After surgery, an average of 3 years after surgery)
- Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.(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.(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.(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.(After surgery, an average of 2 months after inclusion)
- Number of adverse events as assessed by CTCAE v5.0(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.(After surgery, an average of 2 months after inclusion)
- Change From Baseline in Pain Scores on the Visual Analog Scale after biopsy.(at inclusion and after surgery (2 months after inclusion))
- Number of complications as assessed by the classification of Clavien-Dindo(After biopsy, an average of 1 day after inclusion.)
- Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.(After surgery, an average of 2 months after inclusion)
- Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.(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.(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.(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.(After surgery, an average of 2 months after inclusion)
- Overall survival (OS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).(After surgery, an average of 3 years after surgery)
- Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.(After surgery, an average of 2 months after inclusion)
- Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.(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.(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.(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.(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.(After surgery, an average of 2 months after inclusion)