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The Ïã¸ÛÁùºÏ²Ê ECMC GCLP Facility is a standalone facility, located on the ground floor of the Ïã¸ÛÁùºÏ²Ê 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 Ïã¸ÛÁùºÏ²Ê ECMC GCLP Facility supports over 20 trials. The early phase trials portfolio includes Ïã¸ÛÁùºÏ²Ê, 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).Ìý 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 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 and Ïã¸ÛÁùºÏ²ÊH 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.

Check out ourÌýleaflet!

Facility Oversight

Professor John Hartley

Facility Head
john.hartley@ucl.ac.uk

Professor John Hartley is the Facility Head and has overall responsibility for all conduct of work performed within the Ïã¸ÛÁùºÏ²Ê ECMC GCLP Facility. Professor Hartley is Professor of Cancer Studies at Ïã¸ÛÁùºÏ²Ê, Scientific Lead of Ïã¸ÛÁùºÏ²Ê ECMC. He is also Chair of CRUK Centre for Drug Development Protocol Safety and Review Board.

Dr Helen Lowe

Facility Manager
h.lowe@ucl.ac.uk

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.

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Dr Victoria Spanswick

Study Manager
v.spanswick@ucl.ac.uk

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.

Facility StaffÌý

• Leah Ensell, Senior GCLP Facility AnalystÌý

• Yashma Pathak, GCLP Facility AnalystÌý

• Nas Mahmoud, GCLP Facility AnalystÌý

• Sharyar Hadi, GCLP Facility AnalystÌý

CRUK Centre for Drug Development Biomarker CentreÌý

• Riaz Jannoo, Post-Doctoral FellowÌý

• Angeliki Karamani, Research AssistantÌý

• Ridesh Rai, Research TechnicianÌý

Cancer Institute ECMC Quality ManagerÌý

• Melanie Fearon

Publications

Selected publications involving the GCLP Facility:Ìý

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).ÌýÌýÌý

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).Ìý

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).Ìý

Bentham, R et al. Using DNA sequencing data to quantify T cell fraction and therapy response. NATURE 597, 555–560 (2021).Ìý

Childs, A. et al. Whole genome sequencing of single circulating tumor cells from neuroendocrine neoplasms. Endocrine-Related Cancer, 28 (9), 631-644 (2021).Ìý

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).Ìý

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).Ìý

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).Ìý

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).Ìý

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).Ìý

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.Ìý

GCLP Facility staff are members of the TRACERx Consortium.Ìý

Funders

The work conducted in the Facility is supported by:

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