A retrospective validation MSI testing vs MMR in Gastric adenoCa
Research type
Research Study
Full title
A retrospective validation of Biocartis Idylla microsatellite instability testing versus mismatch repair immunohistochemistry in gastric adenocarcinoma biopsies
IRAS ID
275182
Contact name
Ilona Hopkins
Contact email
Sponsor organisation
Royal Cornwall Hospital
Clinicaltrials.gov Identifier
NCT00000000, ClinicalTrials.gov
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
Gastric adenocarcinoma is a common form of cancer which is associated with a poor prognosis. Up to 22% of gastric adenocarcinomas as a result of a DNA mutation which results in impaired protein function. The abnormalities are usually detected via laboratory testing as either a genetic or a protein test. \nThe importance of these abnormalities is that in gastric adenocarcinoma they are shown to benefit from a different therapeutic approach. High concordance between mismatch repair immunohistochemistry [protein] and microsatellite instability [genetic] testing has already been demonstrated. The implementation of either method is largely based on local availability. \nOur department does not currently have the facilities to perform MSI [genetic] testing on any platform, so the advantages of introducing the Idylla MSI test would also include the generic advantages of MSI testing. These advantages include: the ability to quickly check cases shown to have possible MMR loss on IHC (i.e. equivocal cases) with MSI testing; and providing an alternative to MMR IHC for screening of Lynch syndrome, reducing the burden on reporting pathologists and reduce the inter-observer variability associated with IHC interpretation. \nThe Idylla MSI test already demonstrates high concordance with other MSI testing platforms but has yet to be compared to the department’s accepted standard of MMR IHC. This project aims to compare the Idylla MSI test to in-house MMR IHC to establish whether the two methods are concordant in reporting MMR / MSI status in gastric adenocarcinoma.\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0049
Date of REC Opinion
28 Jan 2020
REC opinion
Favourable Opinion