Microfluidic extraction of lymphoma cells from blood
Research type
Research Study
Full title
Microfluidic extraction of large cell lymphoma from blood for characterisation by cytology and cell block immunohistochemistry
IRAS ID
248147
Contact name
Frederick Mayall
Contact email
Sponsor organisation
ANGLE Europe Ltd
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
Research Summary
Large cell lymphoma is the commonest form of lymphoma (https://www.nature.com/articles/bjc201594). This study examines the performance of a simplified method for capturing and typing scarce circulating tumour cells (CTCs) from the blood of patients that have, or are likely to have, large cell lymphoma. It follows on from a similar previous study that involved extracting CTCs from the blood of patients with metastatic carcinoma (IRAS ID: 209687). The method combines two established commercially available technologies; Parsortix (Angle PLC) and CytoFoam Disc (Exmoor Innovations Ltd). The study will be divided into two parts. There will be an initial study of 10 cases. If CTCs can recovered from the blood of the first 10 cases, then a further 40 cases will be tested. There is a published method that will be adapted for this study; Mayall FG, Bodger I, Pepperell J, et al. The precious cell block Journal of Clinical Pathology doi: 10.1136/jclinpath-2018-205151 http://dx.doi.org/10.1136/jclinpath-2018-205151.
A 20 ml blood sample is required.
Angle’s Parsortix microfluidic technology captures circulating tumour cells (CTCs) from blood. The resulting “liquid biopsy” enables the genetic and protein analysis of the patient’s cancer which has the potential to help direct optimal therapy.
Cytofoam Disc is a hydrogel sponge that absorbs cells, from a liquid, within its pores so that they can be examined in formalin fixed paraffin embedded sections, of the type that are used for all routine diagnostic histopathology.
The study will be divided in to two parts. There will be an initial study of 10 cases. If CTCs can recovered from the blood of any of the first 10 cases, then a further 40 cases will be tested. If no CTCs can be recovered from the blood of the first 10 cases then the study will end. See the uploaded protocol.
Summary of Results
Large cell lymphoma is the commonest form of lymphoma. This study examined the performance of a simplified method for capturing and typing scarce circulating tumour cells (CTCs) from the blood of patients that had, or were likely to have, large cell lymphoma. It follows on from a similar previous study that involved extracting CTCs from the blood of patients with metastatic carcinoma (IRAS ID: 209687). The method combined two established commercially available technologies; Parsortix (Angle PLC) and CytoFoam Disc (Exmoor Innovations Ltd). There is a published method that was adapted for this study; https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DPbf8m0AMf80LgKkJSwbdGDh7w8uWMMopN98WAYQI0y2lmojhA21DB2EPg9SjH7tYspTZ0jiLp5E737mym5-2BDmw-3D-3Dyldc_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIUMP6fuXqud9nrFWQMGKcZA1q60x0iyKuLt3eZk-2FIy4wsPOsOfOJxORVNpcdUnxOltabBF1ZOyt59n1N3Kx8FjoGyH3pm8ilyj6jnvstacbknNsT5HClKdl-2BL4YaIdPfKXcBXxPtkEIdweWPl38da0I0Q-2BizRg7TrVMzISq4drqw-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C51543604efc94ea4099108d9d2b87265%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637772511897902828%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=2IB9wHOLM1tD3j%2FjpiaUiusPXLK8f%2BYx53TOWNaWFDU%3D&reserved=0
A 20 ml blood sample was required from each patient.
Angle’s Parsortix microfluidic technology captures circulating tumour cells (CTCs) from blood. The resulting “liquid biopsy” enables the genetic and protein analysis of the patient’s cancer which has the potential to help direct optimal therapy.
Cytofoam Disc is a hydrogel sponge that absorbs cells, from a liquid, within its pores so that they can be examined in formalin fixed paraffin embedded sections, of the type that are used for all routine diagnostic histopathology.
The study was be divided in to two parts. There was an initial study of 10 cases. If CTCs could recovered from the blood of any of the first 10 cases, then a further 40 cases were to be tested. If no CTCs can be recovered from the blood of the first 10 cases then the study would have ended.
Results: Lymphoma cells were recovered from some of the first 10 cases, but only in very low numbers that were insufficient to be diagnostically useful. After 14 cases had been processed using the original method it was decided that continuing the study would be futile unless an improvement could be made in the number of lymphoma cells that were being recovered. Consequently a "substantially amendment" to the original protocol was requested and approved by the research ethic committee. This change involved using Transfix collection tubes to try to improve the preservation of the lymphoma cells in the blood. A further five cases were processed but the yield of cells did not improve enough to be diagnostically useful. After discussion with the sponsor it was decided that processing further samples was futile and the study was ended.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0567
Date of REC Opinion
21 Dec 2018
REC opinion
Further Information Favourable Opinion