Biopsy of Uterine Fibroids of Uncertain Malignant potential
Research type
Research Study
Full title
Preoperative Transcervical Biopsy of Uterine Fibroids of Uncertain Malignant Potential
IRAS ID
180748
Contact name
Michael Wong
Contact email
Sponsor organisation
Joint Research Office
Clinicaltrials.gov Identifier
Z6364106/2016/08/51, UCL data protection registration number
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Uterine sarcomas are a group of rare cancers of the womb, for which leiomyosarcoma is the commonest. They are often difficult to diagnose even with modern medical imaging tests. Sometimes it is only possible to diagnose leiomyosarcoma after hysterectomy (removal of the womb). At University College London Hospitals (UCLH), we have been offering preoperative biopsy (through the vagina) under ultrasound guidance in selected patients with suspected leiomyosarcoma. This approach however is limited by the small sizes of biopsy obtained, which makes reliable diagnosis difficult. In this study, we propose to use immunohistochemistry markers (special stains used to examine cells under microscope) to try to differentiate between cancerous leiomyosarcoma from benign fibroid (muscle overgrowth of the womb). This approach could allow more accurate diagnosis before surgery, therefore those with cancer can be fast-tracked and those with benign fibroid may avoid unnecessary surgery. In this pilot study, we aim to recruit 60 women with uterine fibroids of uncertain malignant potential who are planning surgery (removal of fibroids or the womb) at UCLH over a 2-year period. The study will not alter women’s treatment plan for surgery. The biopsy will be taken in theatre immediate before surgery under general anaesthesia. This biopsy procedure has been shown from our own experience as well as from published studies that it is safe and well tolerated by patients. There has been no report of leiomyosarcoma cancer patients being upstaged or made worse by having preoperative biopsy. All study patients will be followed up for 8 weeks postoperatively or until their first postoperative outpatient clinic appointment.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0408
Date of REC Opinion
10 Nov 2016
REC opinion
Further Information Favourable Opinion