BIOPSAR study: ultrasound-guided pre-operative biopsy to assess histology of sarcoma-suspicious uterine tumors: a new study protocol.
Diagnosis, Differential
Female
France
Humans
Image-Guided Biopsy
/ methods
Leiomyoma
/ diagnostic imaging
Magnetic Resonance Imaging
Multicenter Studies as Topic
Prospective Studies
Randomized Controlled Trials as Topic
Sarcoma
/ diagnostic imaging
Ultrasonography, Interventional
/ methods
Uterine Neoplasms
/ diagnostic imaging
adenosarcoma
sarcoma
surgical oncology
uterine neoplasms
uterus
Journal
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
ISSN: 1525-1438
Titre abrégé: Int J Gynecol Cancer
Pays: England
ID NLM: 9111626
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
accepted:
17
09
2021
pubmed:
1
10
2021
medline:
27
1
2022
entrez:
30
9
2021
Statut:
ppublish
Résumé
The pre-operative differential diagnosis between a uterine leiomyoma and a sarcoma can be a challenge. Available diagnostic tools have difficulty distinguishing between the two pathologies. Τo evaluate the possibility of a pre-operative pathological diagnosis of atypical uterine muscle tumors by vaginal ultrasound-guided biopsy (VUGB). Diagnostic performance of ultrasound-guided biopsy will be capable of differentiating a leiomyoma from a sarcoma with a sensitivity of >90%. A prospective multi-center interventional study will be performed at 10 tertiary French centers. Vaginal ultrasound Doppler examination and pelvic magnetic resonance imaging will be performed before surgery. VUGB will then be performed by a specialist radiologist. The biopsy will be obtained by performing transvaginal ultrasound under local anesthesia with lidocaine using a 16G needle. At least 4-5 specimens will be obtained in order to provide a histopathological diagnosis. All patients included in the study will be operated by laparotomy. All patients included in the study will be followed up for the subsequent 3 years according to their pathological results. All patients >35 years old diagnosed with a suspicious uterine tumor will be included. Sensitivity of VUGB on pathological diagnosis. Considering a sensitivity of 90% (H0) as acceptable and a sensitivity of 95% (H1) as excellent, a sample size of 250 evaluable patients will be necessary to achieve 80% statistical power with a 5% type 1 statistical error. Accrual will be completed in December 2024 with results presented in December 2029. Institutional Review Board (Ethic Committee of Paris Ile de France 6) no 2018-A02343-52.
Sections du résumé
BACKGROUND
The pre-operative differential diagnosis between a uterine leiomyoma and a sarcoma can be a challenge. Available diagnostic tools have difficulty distinguishing between the two pathologies.
PRIMARY OBJECTIVE
Τo evaluate the possibility of a pre-operative pathological diagnosis of atypical uterine muscle tumors by vaginal ultrasound-guided biopsy (VUGB).
STUDY HYPOTHESIS
Diagnostic performance of ultrasound-guided biopsy will be capable of differentiating a leiomyoma from a sarcoma with a sensitivity of >90%.
TRIAL DESIGN
A prospective multi-center interventional study will be performed at 10 tertiary French centers. Vaginal ultrasound Doppler examination and pelvic magnetic resonance imaging will be performed before surgery. VUGB will then be performed by a specialist radiologist. The biopsy will be obtained by performing transvaginal ultrasound under local anesthesia with lidocaine using a 16G needle. At least 4-5 specimens will be obtained in order to provide a histopathological diagnosis. All patients included in the study will be operated by laparotomy. All patients included in the study will be followed up for the subsequent 3 years according to their pathological results.
MAJOR INCLUSION/EXCLUSION CRITERIA
All patients >35 years old diagnosed with a suspicious uterine tumor will be included.
PRIMARY ENDPOINT
Sensitivity of VUGB on pathological diagnosis.
SAMPLE SIZE
Considering a sensitivity of 90% (H0) as acceptable and a sensitivity of 95% (H1) as excellent, a sample size of 250 evaluable patients will be necessary to achieve 80% statistical power with a 5% type 1 statistical error.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
Accrual will be completed in December 2024 with results presented in December 2029.
TRIAL REGISTRATION
Institutional Review Board (Ethic Committee of Paris Ile de France 6) no 2018-A02343-52.
Identifiants
pubmed: 34588215
pii: ijgc-2021-002995
doi: 10.1136/ijgc-2021-002995
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1476-1480Informations de copyright
© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.