Targeted Molecular Testing in Endometrial Carcinoma
Research type
Research Study
Full title
ELECTRA: Expanding the Laboratory diagnosis of Endometrial Carcinoma through Targeted molecular (Next Generation Sequencing) testing based on Risk Assessment
IRAS ID
279703
Contact name
Naveena Singh
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
6 years, 11 months, 31 days
Research summary
Each year over 9000 women in the UK are diagnosed with endometrial carcinoma (EC), the commonest form of cancer affecting the womb. Most ECs have very good outcomes but some can be fatal. Treatment is by surgical removal of the womb, and about one in five patients are given additional radiotherapy and possibly chemotherapy. The treating team needs to accurately recognize cases that will benefit from additional treatment after their surgery.
At present the decision to give additional treatment is based on the appearance of the EC under the microscope and the extent of its spread within the body. The appearance of the EC can be misleading in many cases, and in recent years it has been shown that the changes in the genes of the cancer cells predict its behavior much more accurately. These tests for genetic changes are recommended but not yet widely used in clinical practice.
The aim of the study is to develop a safe, efficient and economical model for delivering this important diagnostic innovation to all EC patients within the NHS. The testing requires two tests that are widely available in NHS pathology laboratories (immunohistochemistry for p53 and mismatch repair proteins), and one assessment that is not currently available (sequencing of the gene encoding polymerase epsilon or POLE).
We will test unused tissue from 700 new EC biopsy samples, using different testing schemes to look for these key genetic changes. We will specifically assess whether or not it is necessary to carry out the testing in all cases or restrict it to only those in whom additional treatment is being considered after surgery. Furthermore we will compare the accuracy of a cheaper test for POLE against the more reliable but expensive one, to see if the former can be safely used as a screening test.
REC name
HSC REC A
REC reference
22/NI/0014
Date of REC Opinion
11 Feb 2022
REC opinion
Further Information Favourable Opinion