Back to resultsDiagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR) (BIOPSAR)
Primary Purpose
Fibroid Uterus, Sarcoma Uterus
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echo-guided uterine biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Fibroid Uterus focused on measuring Uterine fibroma, Suspect uterine sarcoma, Echo-guided biopsy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Institut Bergonié
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm echo-guided uterine biopsy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
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)
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).
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.
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.
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.
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).
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).
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).
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.
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).
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.
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).
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)
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.
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.
Number of complications as assessed by the classification of Clavien-Dindo
Complications related to biopsy will be evaluated after biopsy.
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.
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
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).
Full Information
NCT ID
NCT04250766
First Posted
November 15, 2019
Last Updated
April 10, 2020
Sponsor
Institut Bergonié
Collaborators
GIRCI SOHO
1. Study Identification
Unique Protocol Identification Number
NCT04250766
Brief Title
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)
Acronym
BIOPSAR
Official Title
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
Collaborators
GIRCI SOHO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroid Uterus, Sarcoma Uterus
Keywords
Uterine fibroma, Suspect uterine sarcoma, Echo-guided biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
275 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm echo-guided uterine biopsy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Echo-guided uterine biopsy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Sensitivity (Se) of preoperative vaginal ultrasound-guided biopsy (VUGB) in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Secondary Outcome Measure Information:
Title
Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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).
Time Frame
After surgery, an average of 2 months after inclusion
Title
Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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)
Time Frame
After surgery, an average of 2 months after inclusion
Title
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.
Description
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).
Time Frame
After surgery, an average of 2 months after inclusion
Title
Specificity (Sp) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Accuracy of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Youden's index (J) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Positive Predictive Value (PPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Description
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).
Time Frame
After surgery, an average of 2 months after inclusion
Title
Negative Predictive Value (NPV) of VUGB in the pathological diagnosis of suspected sarcoma uterine tumors based on the centralized review by an expert pathologist.
Description
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).
Time Frame
After surgery, an average of 2 months after inclusion
Title
Sensitivity (Se) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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).
Time Frame
After surgery, an average of 2 months after inclusion
Title
Specificity (Sp) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Accuracy of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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).
Time Frame
After surgery, an average of 2 months after inclusion
Title
Youden's index (J) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Positive Predictive Value (PPV) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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).
Time Frame
After surgery, an average of 2 months after inclusion
Title
Negative Predictive Value (NPV) of imaging (MRI coupled with echo-guided biopsy) in the pathological diagnosis of suspected sarcoma uterine tumors.
Description
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)
Time Frame
After surgery, an average of 2 months after inclusion
Title
Reproducibility of local histopathological reading and centralized review by an expert pathologist of the echo-guided uterine biopsies.
Description
Cohen's Kappa coefficient. kappa coefficient values greater than 0.75 correspond to acceptable reproducibility.
Time Frame
After surgery, an average of 2 months after inclusion
Title
Change From Baseline in Pain Scores on the Visual Analog Scale after biopsy.
Description
The minimum value is 0 and the maximum value is 10. A high score of pain indicates a high level of pain.
Time Frame
at inclusion and after surgery (2 months after inclusion)
Title
Number of complications as assessed by the classification of Clavien-Dindo
Description
Complications related to biopsy will be evaluated after biopsy.
Time Frame
After biopsy, an average of 1 day after inclusion.
Title
Number of adverse events as assessed by CTCAE v5.0
Description
Adverse events will be evaluated at inclusion, on the day of the biopsy and after the biopsy.
Time Frame
an average of 2 months after inclusion
Title
Progression-free survival (PFS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).
Description
PFS is defined as the time interval between the date of surgery and the date of progression and/or death whichever occurs first
Time Frame
After surgery, an average of 3 years after surgery
Title
Overall survival (OS) rate for atypical or dubious uterine sarcomas or fibroids (STUMP).
Description
OS is defined as the time interval between the date of surgery and the date of death (of any cause).
Time Frame
After surgery, an average of 3 years after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédéric GUYON, MD
Phone
05.56.33.78.30
Ext
+33
Email
f.guyon@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Simone MATHOULIN-PELISSIER, MD, PhD
Email
s.mathoulin@bordeaux.unicancer.fr
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric GUYON, MD
Phone
05.56.33.78.30
Ext
+33
Email
f.guyon@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Denis QUERLEU, MD, PhD
Email
d.querleu@bordeaux.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)
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