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

Launched by CHARLES UNIVERSITY, CZECH REPUBLIC · Jul 22, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "The Role of Pre-Surgical Tru-Cut Biopsy in the Management of Atypical Myometrial Lesions," is designed to study how a specific type of biopsy, called a Tru-cut biopsy, can help doctors better understand unusual growths in the uterus before surgery. The focus is on women who have atypical myometrial lesions, which are abnormal growths that might look like fibroids but could potentially be a more serious condition called leiomyosarcoma. By using this biopsy technique, the researchers hope to provide more accurate information about the nature of these tumors, which can help tailor safer treatment options for patients who may need surgery.

To participate in this study, women must be at least 18 years old and scheduled for either a uterus-preserving surgery or a hysterectomy due to these atypical lesions. They also need to give their consent to join the study. Participants will undergo the Tru-cut biopsy to gather tissue samples for analysis. The study will also look at how this procedure affects the participants' quality of life and overall clinical management. It’s important to note that certain conditions, such as ongoing pregnancy or specific medical issues, may exclude someone from participating in this trial. If you or someone you know is interested in learning more, this study could offer valuable insights into the management of atypical growths in the uterus.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • patient 's refusal
• • age \< 18 years
• • ongoing pregnancy
• • inability to perform TCB /contraindications for TCB (trombocytopenia, coagulopathy, PID, colpitis) or definitive surgery (myomectomy or hysterectomy)
• • 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
• • history of conservative hormonal therapy less than 3 months prior to study enrolment
• • history of conservative therapy via uterine artery embolisation or laparoscopic uterine artery occlusion
• • history of pregnancy less than one year prior to study enrollment