Methylated biomarkers predictive of endometrial cancer risk

• Research type

  Research Study

• Full title

  Methylated biomarkers predictive of endometrial cancer risk-BioMEC study

• IRAS ID

  334940

• Contact name

  Sarah Kitson

• Contact email

  sarah.kitson@manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Womb cancer is the fourth commonest cancer in women and case numbers are rising rapidly. The only way to slow down this increase is to prevent women from developing the disease in the first place. Clinical trials aimed at finding the most effective approach to preventing womb cancer would need to include large numbers of women and follow them up for 10 years+ if they are to show a decrease in the number of womb cancer diagnoses. A risk predictive biomarker could provide an early read-out of the effectiveness of any trialled interventions, reducing both the cost and duration of future studies. Unfortunately, no such biomarkers have been ratified for use in womb cancer prevention trials. This study aims to identify and validate a womb cancer risk predictive biomarker and to see if it can be tested for in minimally-invasive samples, as more acceptable alternatives to repeated womb biopsies.
  Women aged 45-70 years attending St Mary’s Hospital, Manchester for a hysterectomy, either as part of their womb cancer treatment or for other non-cancer related reasons, will be asked to take part in the study. Participants will be asked questions about their general health, periods and childbirth and to provide a urine, blood and cervicovaginal sample on the day of their surgery either whilst they are waiting to go to theatre or when they are already in theatre and under anaesthesia. A biopsy of the womb lining will be collected under anaesthesia. Participant involvement in the study will end once these samples have been collected. In addition, blocks of tissue will be accessed from the hysterectomy specimen once all clinical diagnostic work has been completed. Anonymised samples will be sent to Dr Belinda Nedjai at Queen Mary University of London for DNA extraction and methylation analysis.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  24/NW/0076

• Date of REC Opinion

  21 Mar 2024

• REC opinion

  Favourable Opinion