The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions
NCT Number: NCT06521060
Acronym: MYSTR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Leiomyosarcoma
Interventions: PROCEDURE: tru cut biopsy
Sponsor: Charles University, Czech Republic
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2028-06
Locations: General hospital, Praha, 12800, Czechia

Summary:
The Tru-cut biopsy (TCB) for targeting pelvic tumors is well established in gynecologic oncology. However, its reliability for differentiating of uterine sarcoma in "myoma-like" uterine lesions has been confirmed by only a few studies, which were either retrospective or provided only pilot result on the limited number of prospectively enrolled patients (N=34). Proving that preoperative TCB can provide accurate information about the histological nature of the tumor would have great impact for setting an adequate tailored oncologically safe approach, especially in patients with sonographically atypical lesions. Additionally, the biopsy should be safe, with transcervical, transuterine cavity ("in organ" biopsy) approaches preferred to avoid the risk of needle canal contamination if sarcoma is diagnosed. The purpose of this study is to evaluate the accuracy of the Tru-cut biopsy (TCB) of sonographically atypical myometrial lesions as a complementary diagnostic method in the preoperative management of patients scheduled for uterus preserving procedure or hysterectomy. Additionally, we aim to assess the impact of this procedure on patients´ quality of life and clinical management. MYSTR is a single arm, prospective, multicentric cohort study.

Primary Outcome Measures: Rate of accuracy, Accuracy is defined as the concordance of the results of preoperative histology from TCB with the result of definitive histology from the operative specimen, 3 years
Secondary Outcome Measures: Rate of adequately performed TCBs, defined as the number of TCBs with adequate encroachment of the lesion with bioptic needle (by the US) and sufficient tissue sample for the histopathological analysis to the total number of TCBs., 3 years|Number of complications, number of complications after TCB divided by the number of patients. Intraoperative and early post-procedural complications will be assessed using a questionnaire. Adverse events will be assessed 14th post-TCB day according to the Clavien-Dindo Surgical complications classification, 3 years|Pain associated with TCB, Assessment of patient´s pain during, 30 minutes after, and 24 hours after the procedure using the Numeric rating scale (NRS), 24 hours|Comparison of the preoperative MRI examination to US imaging, Testing the superiority of either approach, sensitivity and specificity of the MRI imaging when compared to US examination will be analyzed, 3 years|Patient satisfaction with the diagnostic MRI and TCB, 1 questionnaire: Patient experience of the diagnostic modalities will be assessed using developed and validated Patient Satisfaction Questionnaire, 3 years|Impact of TCB on clinical management, the change of clinical management of patients with uterine "myoma-like" tumors caused by the TCB histology results (frequency of open surgeries and rate of necessary use of contained morcellation during laparoscopic myomectomy or hysterectomy), 3 years|Frequency of non-standard histological findings, the frequency of atypical histological findings (other than conventional leiomyoma) from the results of definitive histology in the group of women with sonographically atypical initial findings, 3 years|Validation of the US markers of atypical myometrial lesions, External validation of the MUSA statement and/or Basel sarcoma scale score (BSS), correlation of respective imaging score and final pathology result, 3 years