Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06521060

The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions

Sponsor: Charles University, Czech Republic

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2024-10

Completion Date

2028-06

Last Updated

2024-07-25

Healthy Volunteers

Yes

Conditions

Interventions

PROCEDURE

tru cut biopsy

Proving that preoperative TCB could provide accurate information about the histological nature of the tumor would have great impact for setting an adequate, tailored, oncologically safe treatment approach.

Locations (1)

General hospital

Prague, Czechia