NCT06521060Not yet recruiting
The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions
Source: ClinicalTrials.gov · Last updated 25 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 3 Dec 2023
- Start date
- Oct 2024
- Primary completion date
- Jan 2027
- Lead sponsor
- Charles University, Czech Republic
- Diseases
- Sarcoma
- NCT number
- NCT06521060
What you commit to
- Study type: Observational
- Planned participants: 250
- From Oct 2024 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- history of conservative therapy via uterine artery embolisation or laparoscopic uterine artery occlusion
Age
- age \< 18 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.