ENABLE - NGS
Research type
Research Study
Full title
Improving diagnosis in chronic lymphoproliferative disorders
IRAS ID
182158
Contact name
Sunil Iyengar
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Patients with a persistent high white cell count with or without swollen glands/ lymph nodes are often diagnosed with cancers of the lymphatic system. However a significant proportion of these patients are not assignable to a specific category based on current technology. This can have an adverse impact on their treatment as the optimal treatment in these unclassifiable cases is not clear. Moreover, these patients are often excluded from entry into clinical trials and so cannot access new drugs. In many cases of lymphatic cancer received by the Royal Marsden, a specific category cannot be assigned using current technology. Recently, new genetic technologies have identified a number of key mutations associated with lymphatic cancers. We propose to introduce these new genetic tests to improve categorisation of these disorders in order to improve patient outcomes by increasing opportunities for entry into clinical trials as well as identifying new therapeutic targets.
It is estimated that the number of indolent B-Cell Lymphoproliferative Disease (B-LPD) cases that are assigned a definitive category using current technology is 30%.
Our plan therefore is to systematically study unclassifiable groups of B-LPD by creating a well defined immunomorphology work flow for their identification. Samples thus identified will be screened using an Next Generation Sequencing (NGS) panel which is able to detect well established, B-LPD associated genetic aberrations including IgH translocations and genetic mutations.
Based on the numbers above, we are looking to screen at least 120 samples over 2 years with the hypothesis that mutation screening will increase the number of cases with a definitive diagnosis or detectable mutation by at least 15%,
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
16/LO/0375
Date of REC Opinion
30 Mar 2016
REC opinion
Favourable Opinion