Tru-cut needle biopsy before surgery for uncertain uterine growths
Tests a needle biopsy before surgery to check uncertain uterine growths for leiomyosarcoma in adults.
Plain-language title generated from the registry record
Registry title: The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions
Key facts
- Where
- Prague, CzechiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06521060, who can take part
Where in Czechia
- General hospitalPrague, CzechiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charles University, Czech Republic
- Trial code
- NCT06521060
- Record updated
- 25 July 2024
- Original description
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.Read full original descriptionShow less
The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions
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.
Inclusion: Signed informed consent; Age ≥ 18 years; Women indicated for uterus-preserving surgery (tumour resection) or hysterectomy for myometrial lesion ('myoma-like' uterine tumour(s)); USG finding of atypical myometrial lesion/s a.
Exclusion: inability to perform TCB /contraindications for TCB (trombocytopenia, coagulopathy, PID, colpitis) or definitive surgery (myomectomy or hysterectomy); history of conservative hormonal therapy less than 3 months prior to study enrolment; history of pregnancy less than one year prior to study enrollment; history of conservative therapy via uterine artery embolisation or laparoscopic uterine artery occlusion; age < 18 years; patient 's refusal; ongoing pregnancy; USG finding of more than 2 atypical lesion/s with a diameter ≤ 20 mm and ≥ 100 mm; inability to perform any of the 3 core needle biopsy approaches (transvervical, trans uterine cavity, transvaginal) because of anatomical, localization issues. The percutaneous transabdominal biopsy is not allowed; Polymyomatous uterus that may not be examined adequately with routine transvaginal ultrasound; myoma (which would be subject to TCB) type 7 according to FIGO classification 16.