p53 in Endometrial Carcinoma
Research type
Research Study
Full title
Laboratory evaluation study of the concordance between p53 immunohistochemical expression pattern and TP53 mutation status in Endometrial Carcinoma
IRAS ID
209675
Contact name
Naveena Singh
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Background: Endometrial (womb) cancer (EC) shows a range of underlying acquired genetic changes (ie mutations). Aggressive ECs often have a “driver” mutation (ie one that causes the cancer and makes it progress) in the TP53 gene. Testing tumour tissue for mutations is currently unavailable/costly, however, testing for the protein p53, the product of this TP53 gene, is generally available at low cost.
Abnormal p53 protein expression is widely held to indicate underlying TP53 mutation, however, expression of p53 and its interpretation are influenced by technical factors and pathologists’ training. In addition, recent research shows that some ECs with phenomenally high mutation rates may show TP53 mutation, but it is unknown whether these show similar p53 expression to those with TP53 driver mutations.
The main aim of the study is to find out whether p53 (protein) expression can give us enough information about the presence and nature of the TP53 mutation in a patient’s endometrial cancer so that it can be used for planning treatment at the time of her first biopsy diagnosis.
Study Design: A maximum of 10 pseudo-anonymised unstained slides of tissue left over from 200 diagnostic biopsies will form the study material, to be used for staining for different proteins and extraction of tumour DNA.
Staining for p53 will be carried out at a reference laboratory. DNA taken from the tumour will be analysed for the presence of TP53 mutation.
For each case the local p53 protein result obtained at the time of the initial biopsy diagnosis will be compared with the reference result and with the presence or absence of TP53 mutation, to determine the full range of p53 expression patterns.
The study will be carried out at academic centres in the UK, the Netherlands and Canada.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0155
Date of REC Opinion
20 Jan 2017
REC opinion
Favourable Opinion