Circulating Neuroblastoma Tumour Cell Study (Version 2.0)
Research type
Research Study
Full title
Collection of Circulating Neuroblastoma Tumour Cells to undertake genetic analyses and establish biomarkers for novel neuroblastoma treatments.
IRAS ID
123694
Contact name
Deborah A Tweddle
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
BH122724, Joint Research Office Reference Number
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Neuroblastoma is the commonest extra-cranial, childhood,solid tumour with around 100 new cases/year in the UK. At presentation, 50% of patients have high-risk disease and only 50% of such patients are long term survivors. This is largely due to development of drug resistance leading to disease relapse. New treatments and a better understanding of drug resistance are needed to improve survival. Circulating tumour cells (CTCs) are a potentially useful source of tumour material on which to test new treatments in the laboratory including MDM2/p53 inhibitors which are now entering clinical trials in adults.
Specific Aims
1) To detect CTCs from blood and bone marrow from neuroblastoma patients at diagnosis and relapse.
2) To use CTCs to develop markers of new treatments ( biomarkers) which may be useful for future clinical trials of patients with neuroblastoma.
3) To determine the genetic characteristics of CTCs.Methods
Neuroblastoma CTCs will be identified in matched blood and bone marrow from neuroblastoma patients using an ImageStream flow cytometer and a fluorescence activated cell sorter. The CTCs will be exposed to novel agents including MDM2/p53 inhibitors. Nucleic acids will be extracted for genetic characterisation including DNA, RNA and protein analyses.Outcomes:
1) The detection of neuroblastoma CTCs may lead to their use in biomarker studies of new treatments for neuroblastoma.
2)Genetic characterisation of CTCs may provide an alternative source of material for determining the genetic status of neuroblastoma without the need for biopsy in some cases.
3) If a suitable biomarker for MDM2/p53 inhibitors in neuroblastoma CTCs is established, this assay could be used in a Phase I clinical trial.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
14/NW/0154
Date of REC Opinion
10 Mar 2014
REC opinion
Favourable Opinion