UCL ECMC GCLP Facility
The UCL ECMC GCLP Facility is a standalone facility, located on the ground floor of the UCL Cancer Institute, specifically designed for the purpose of clinical trial sample handling analysis and storage. The Facility operates to the principles of GCLP in order to ensure that all work for clinical trials is carried out in accordance with the current MHRA regulations, from translational experiments, through method development and validation, to clinical trial sample analysis.
The UCL ECMC GCLP Facility supports over 20 trials. The early phase trials portfolio includes UCL, CRUK and commercially sponsored trials in multiple modalities including chemotherapy, radiotherapy and immunotherapy.
The Facility has Full Accreditation in Good Clinical Laboratory Practice (Accreditation number 06519, Qualogy 2002 Ltd). Good Clinical Laboratory Practice (GCLP) is a quality system for laboratories that analyse samples from Clinical Trials in accordance with Good Clinical Practice (GCP) regulations. Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and data reporting of clinical trials that provides assurance that the data and the reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.
The Cancer Research UK Centre for Drug Development Biomarker Centre was awarded to the GCLP Facility in 2017 upon tender bid between national ECMCs. The Biomarker Centre has the aim of developing and validating novel biomarker assays for early phase clinical trials with the use of pharmacodynamic and stratification biomarker technologies to identify and progress new treatments for the patients benefit.
The Facility is aligned with the NIHR UCLH Clinical Research Facility and UCLH Macmillan Cancer Centre, where patients are supported throughout their involvement in clinical research. This alignment enables ease of transfer of clinical trial samples between laboratories following patient treatment, as well as supporting each site in their research.
Professor John Hartley
Professor John Hartley is the Facility Head and has overall responsibility for all conduct of work performed within the UCL ECMC GCLP Facility. Professor Hartley is Professor of Cancer Studies at UCL, Scientific Lead of UCL ECMC. He is also Chair of CRUK Centre for Drug Development Protocol Safety and Review Board.
Dr Helen Lowe
Responsibilities include staff training, equipment provision and maintenance, generation of Laboratory Agreements and the Facility finances. Dr Lowe works with the QA Manager, Document Controller and Archivist, to ensure continual improvement of the Quality Management System, and the generation, maintenance and archiving of clinical trial documentation.
Dr Victoria Spanswick
Provides scientific contributions in the translational aspect and protocol development of clinical trials and studies within a Good Clinical Laboratory Practice (GCLP) environment.
Oversees all aspects of clinical trial implementation, sample analysis and data integrity within the Facility from start up, during active trial to final data reporting.
Leah Ensell, Senior GCLP Facility Analyst
Yashma Pathak, GCLP Facility Analyst
Nas Mahmoud, GCLP Facility Analyst
Sharyar Hadi, GCLP Facility Analyst
CRUK Centre for Drug Development Biomarker Centre
Riaz Jannoo, Post-Doctoral Fellow
Angeliki Karamani, Research Assistant
Ridesh Rai, Research Technician
Cancer Institute ECMC Quality Manager
Selected publications involving the GCLP Facility:
Propper, D et al. PANTHER: AZD8931, inhibitor of EGFR, ERBB2 and ERBB3 signalling, combined with FOLFIRI: a Phase I/II study to determine the importance of schedule and activity in colorectal cancer. British Journal of Cancer 128, 245–254 (2023).
Beaton, L. et al. Phase 0 study of vandetanib-eluting radiopaque embolics as a pre-operative embolization treatment in patients with resectable liver malignancies. Journal of Vascular and Interventional Radiology 33 (9), 1034-1044 (2022).
Roddie, C. et al. Durable Responses and Low Toxicity After Fast Off-Rate CD19 Chimeric Antigen Receptor-T Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. Journal of Clinical Oncology 39 (30), 3352-3363 (2021).
Bentham, R et al. Using DNA sequencing data to quantify T cell fraction and therapy response. NATURE 597, 555–560 (2021).
Childs, A. et al. Whole genome sequencing of single circulating tumor cells from neuroendocrine neoplasms. Endocrine-Related Cancer, 28 (9), 631-644 (2021).
Mandair, D. et al. Prognostic Threshold for Circulating Tumor Cells in Patients With Pancreatic and Midgut Neuroendocrine Tumors. The Journal of Clinical Endocrinology & Metabolism, 106 (3), 872-882 (2021).
Forsyth, S. et al. POPPY: A phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status 2 with recurrent or metastatic squamous cell carcinoma of the head and neck. Annals of Oncology, 31 (4), S686-687 (2020).
Forster, M et al. EACH: A phase II study evaluating the safety and anti-tumour activity of avelumab and cetuximab in recurrent/metastatic squamous cell carcinomas. Annals of Oncology, 31 (4), S665 (2020).
Chemi, F. et al. Pulmonary venous circulating tumor cell dissemination before tumor resection and disease relapse. NATURE MEDICINE 25, 1534-1539 (2019) & 26 (7) 1147 (2020).
Rizzo, F. M. et al. Circulating tumour cells and their association with bone metastases in patients with neuroendocrine tumours. Br. J. Cancer 120, 294–300 (2019).
GCLP Facility staff are members of the COG-UK Consortium which was set up in response to the Covid-19 pandemic. For COG-UK publications you can visit this PubMed page.
GCLP Facility staff are members of the TRACERx Consortium.
The work conducted in the Facility is supported by: