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Establishing a Biobank and Database as a National Resource for Characterising Indolent and Aggressive forms of Mantle Cell Lymphoma, an Observational Study.

Mantle Cell Lymphoma (MCL) is a type of nonHodgkin’s lymphoma a cancer of the lymphocytes (white blood cells) that occurs when the growth of these cells is out of control. MCL is a relatively rare, usually aggressive cancer for which there is currently no known cure. Many patients are treated as soon as they are diagnosed because they generally have a poor prognosis. However, our experience tells us that there is a subset of patients that have a less aggressive form of the disease. They can remain asymptomatic, sometimes for years. These patients need not be treated with systemic chemotherapy straight away and `watching and waiting’ does not affect the outcome at all. There are currently no tests that can tell us which patients have indolent behaving disease at diagnosis. Knowing this will be really helpful in finding the best way to treat people with this disease in the future. The only way that we can really be sure which type of MCL a patient has, is to observe what happens to them over the next few years. We will collect baseline blood and saliva samples, diagnostic biopsy material and clinical information from patients who are newly diagnosed with MCL. These samples will be stored in a Biobank. After this, patients will not directly be involved as the information we need to collect can be found in the medical notes. We aim to recruit 300 participants over 3 years. Once the study is completed, we will know which patients have indolent MCL and which patients have aggressive MCL. We will then study the stored samples to try to identify and understand the differences between indolent and aggressive forms of MCL.

Inclusion criteria:
aged 16 and over newly diagnosed mantle cell lymphoma able to give consent

Exclusion criteria:
Received systemic treatment for mantle cell lymphoma (localised radiotherapy is acceptable)

Principal Investigator for this trial: Dr Christopher P Fox

Research Ethics Committee Reference: 14/WA/1192

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

Nottingham Health Science Biobank awarded approval from the Human Tissue Authority

After a site visit to NUH in April, the HTA found the Nottingham Health Science Biobank to fully satisfy their rigorous criteria for approval.
The HTA found the Designated Individual and the Licence Holder to be suitable in accordance with … Continue reading

Nottingham Health Science Biobank

by Balwir Matharoo-Ball

The Nottingham Health Science Biobank (NHSB) and related bioinformatics strategy as a platform for excellence in translational and clinical research is led by Dr Brian Thomson Director of Department of Research and Innovation (R&I) and the NHSB. This … Continue reading

Nottingham Research Biobank gains Ethics Approval

The Nottingham Research Biobank has now received Ethical Approval. This is the first formal step in our co-ordinated biobanking and patient informatics strategy. The Ethics approval itself has a number of unique features, and is by far the most comprehensive … Continue reading

UK Multicentre Study of Children with Opsoclonus Myoclonus Syndrome (UMSCOM) This is the UK arm of EU study “Multinational Européan Trial for Children with the Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome”.

Opsoclonus myoclonus syndrome (OMS) is a rare disorder of the nervous system (incidence 1/5 million/year) with
onset usually in the second year of life. It presents as jerky movements of the eye (opsoclonus) and body (myoclonus), with ataxia, irritability and sleep disturbance, and is associated with subsequent learning, movement and behavioural problems. About 50% of children with OMS have an underlying neuroblastoma and it seems likely that it is an immunemediated, sometimes paraneoplastic, condition. Steroids, often supplemented with other immunosuppressants, are the primary treatment but there is limited evidence for drug choice and dosage and little knowledge of the relationship between early symptomatic response and later cognitive outcome. This study will examine drug response of OMS children, with and without NB. 100 children (15 from the UK), recruited over 3 years across 8 European countries, will be treated with an escalating 3step schedule. All will receive a pulse of dexamethasone (3 consecutive daily doses) at diagnosis and then at a further eleven 4weekly intervals. Children who fail to show marked benefit after three pulses of
dexamethasone will additionally receive cyclophosphamide at each of the next three or six dexamethasone pulses.
Those who show inadequate improvement after 3 doses of cyclophosphamide will in its place receive two doses of
rituximab at 2weekly intervals. The primary outcome measure will be remission of OMS symptoms/signs as recorded by the clinician. For each treatment group the final statistic will be percentage of participants in disease remission
Secondary outcome measures will be improvement in OMS symptom score and cognitive and behavioural outcome. A
European biobank
will be established.

Inclusion criteria:
For inclusion in the study all three numbered criteria below must be satisfied:
1) A diagnosis of OMS: Three out of the following four components must be evident:
• Opsoclonus or ocular flutter (but not nystagmus)
• Ataxia and/or myoclonus
• Behavioural change and/or sleep disturbance
• Neuroblastoma
2) Age at diagnosis between 6 months and 7 years (up to 8th birthday).
3) Signed informed consent has been given

Exclusion criteria:
1. Opsoclonus, myoclonus or ataxia caused by another identified disease.
2. Prior or parallel use of chemotherapy (other than required for treatment of NB)
3. Steroid treatment lasting 14 days or more immediately before start of the study.

Principal Investigator for this trial: Dr William Whitehouse

Research Ethics Committee Reference: 13/LO/0706

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

Talomere characteristics and genetic profile of high-grade soft tissue sarcoma

Soft tissue sarcomas (STSs) are a group of cancers that affect many structures including muscles, nerves, tendons and blood vessels. About 3800 new cases are diagnosed annually in the UK, making up 1% of all new adult cancer diagnoses. The treatment of STSs centres on the surgical removal of tumours and radiotherapy. Even after treatment over 50% of tumours return or `recur’. This is a difficult problem to manage, and in many cases will be incurable. Currently there is no test to identify which patients with STS will suffer recurrence. We aim to identify biomarkers, primarily geneticmarkers, that distinguish between the patient’s tumour and normal cells. We will develop assays to detect specific biomarkers and determine whether they can be used to track the tumour markers in patients over time. We will investigate the relationship between detection of tumourspecific markers and patient outcome. This may allow doctors to identify patients at `at risk’ of relapse or recurrence early, and potentially instigate more aggressive treatments to tackle recurrence. Patients with STS who are managed by the East Midlands Sarcoma Service will be approached to participate. They will either be treated at the Leicester Royal Infirmary or Nottingham City Hospital. After appropriate consent has been given, tissue samples will be collected and stored in the Nottingham Health Science Biobank. The research on the samples collected from patients will take place at the University of Leicester / Leicester Royal Infirmary.

Inclusion criteria:
1) Cases of nonmetastatic biopsy proven highgrade soft tissue sarcoma (STS) presenting to the East Midlands Sarcoma Service 2) Cases to be treated with curative intent with surgical resection (+/ adjuvant therapy)

Exclusion criteria:
1) Cases presenting with local of distant recurrence 2) Retroperitoneal soft tissue sarcomas 3) Patients unable to provide informed consent 4) Patients aged under 18

Principal Investigator for this trial: Mr Robert U Ashford

Research Ethics Committee Reference: 14/NE/1192

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

Nottingham University Hospitals to play key role in DNA cancer project

Nottingham University Hospitals, in collaboration with local partners, is taking part in a major national initiative that aims to transform diagnosis and treatment for patients with cancer and rare diseases.
NHS England has announced that a partnership between Nottingham University Hospitals, … Continue reading

Arthritis Research UK Centres

The Arthritis Research UK Pain Centre
The Arthritis Research UK Pain Centre investigates the mechanisms that lead to the chronic pain experienced by sufferers of arthritis, in order to improve the treatment of that pain. Research is undertaken by a multidisciplinary … Continue reading

NIHR Nottingham Hearing Biomedical Research Unit and Medical Research Council launch study into loud music and hearing loss

Researchers from the MRC and the Nottingham NIHR Hearing BRU have launched a unique mass participation study to see if listening to loud music is contributing to the increase in hearing loss in the UK population.

NUH Research, Development and Innovation Annual Report 2012/13

During 2012/13 NUH delivered significant improvements in research initiation and delivery. Performance against NIHR contract benchmarks for research initiation and delivery improved by 36% yoy

Phenotypic characteristics, immune interactions and ultrahigh field imaging of autologous mesenchymal stem cells from MS patients

This project will take advantage of a uniquely favourable setting at Nottingham University to investigate the therapeutic potential and functional and phenotypic features of mesenchymal stem cells (MSC) in multiple sclerosis (MS). MS is the most common cause of neurodisability in young adults. It is an immune mediated inflammatory attack against CNS myelin and neurons causing long-term dysfunction related to chronic demyelination and axonal degeneration. The aim
of the study is to characterise a group of stem cells (MSC) from the bone marrow of patients with MS. These cells have a great potential for being used for stem cell treatments in MS because they have both immunomodulatory and neuroprotective/ neurorepair qualities. We will harvest MSC from patients with MS of secondary progressive type and healthy volunteers by bone marrow biopsy, and enrich by plastic adherence and serial passages in culture dishes. We will characterize MSC phenotypically using typical markers, assess responses to inflammatory stimuli and behaviour
in interaction with autologous immune cells. MSC and their interactions will be compared between MS and control
subjects and between various passages. Many studies have looked at MSC in isolation or together with immune cells from other donors of from animals with MS-like disease, but few have looked at the interaction of these cells with
immune/inflammatory cells form the same donor. This will help predict how these cells will behave when they are
infused back into patients with MS. We will also study in vitro magnetically labelled MSC with a very high field magnetic resonance microscope to see whether we can image them with an ultra-high field MRI field. These studies will provide important information and help optimise the design of MSC treatment trials.

Inclusion criteria:
diagnosis of SPMS with or without superimposed relapses for at least 1 year
EDSS 3.07.0
age 25-70
male or female patients
female patients of childbearing potential must not be pregnant and use appropriate contraception at the time of the bone marrow biopsy
ability to give informed consent
Healthy donors:
subjects without immunological diseases, aged 25-70 y
ability to give informed consent

Exclusion criteria:
Inability or unwillingness to give informed consent
Known allergy to any of the drugs used for the bone marrow aspiration including local anesthetic or pain control
Pregnancy or lactating females
Currently or in the previous 1 months taking disease modifying or immunomodulatory therapy (beta interferon,
glatiramer acetate, systemic glucocorticoids) currently or in the previous 3 months taking natalizumab currently or in
the previous 3 months taking immunosuppressive medication (including but not limited to mitoxantrone,
mycophenolate, tacrolimus, currently or in the previous 6 months taking cyclophosphamide currently or in the previous
2 years having undergone haematopoietic stem cells transplantation.
Any known serious systemic illness (cardiovascular / respiratory / renal / gastrointestinal / hepatic / any malignancy)
apart from multiple sclerosis
Unable to tolerate venepuncture
Taking medicines that affect blood clotting (e.g Aspirin in the last week, clopidogrel, warfarin etc)
Unable to tolerate bone marrow aspiration (including known allergy/adverse reaction to local anaesthetic or
allergy/adverse reaction to pain killer)
Any medical, psychiatric or other condition that could result in a subject being unable to give fully informed consent or
to comply with the protocol requirements
Any other medical or psychiatric condition which, in the opinion of the Investigator, makes the subject an unsuitable
participant in this trial.
Healthy donors:
Inability or unwillingness to give informed consent
Known allergy to any of the drugs used for the bone marrow biopsy including local anaesthetic or pain control
Pregnancy or lactating females
Any known serious systemic illness (cardiovascular / respiratory / renal / gastrointestinal / hepatic / any malignancy)
Unable to tolerate venepuncture
Unable to tolerate bone marrow biopsy
Any medical, psychiatric or other condition that could result in a subject being unable to give fully informed consent or
to comply with the protocol requirements
For subjects who choose to donate their MSC to the Nottingham Health Science Biobank (using an additional consent
form and Information Sheet), the following groups will be excluded:
· those who have had liver disease
· those with tuberculosis
· those who have received pituitary derived growth hormone/gonadotrophin
· those who have received insulin or steroids over a long period
· those who have unexplained travel fever
· those who have had rabies
· those who have had malaria
· those who have had a blood transfusion since 1980
· those who have SLE (lupus)
· l) recipients of organ/tissue transplants
· m) those who have had a tattoo/body piercing/acupuncture (by a nonregistered acupuncturist) in the last 6 months
· n) recipients of human dura mater including people who have had brain surgery or an operation to remove a tumor
or cyst of the spine before August 1992
· o) those diagnosed or suspected of suffering from CJD or have a family history of CJD
· p) those with degenerative neurological disease of unknown causation
· q) any condition where an altered immune system or viral involvement is suspected or implicated.

Principal Investigator for this trial: Professor Cris S Constantinescu

Research Ethics Committee Reference: 12/EM/0263

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

EMAHSN 4th March event: Igniting Innovation – Experimental Medicine – Working Together

The East Midlands Academic Health Science Network and Medilink are hosting an event entitled ‘IGNITING INNOVATION’ EXPERIMENTAL MEDICINE – WORKING TOGETHER on Monday 4 March 2013 at BioCity, Nottingham.

NUH maintains excellence in research in a challenging NHS environment

During 2011/12 NUH maintained excellence in research in a changing and challenging environment. Key achievements during this period include 8,874 patients recruited in 293 NIHR adopted studies, 1644 patients recruited to 157 commercial studies, 14 new NIHR research grants awarded, £8.7M external funding attracted by three BRUs, More than 4,000 biosamples and £420K of external funding for the Nottingham Health Science Biobank. Continue reading

Leica Testimonial

Nottingham University Hospitals ‐ Delivering exceptional service for external clinical evaluations
The external evaluation of any diagnostic kit is the cornerstone for the commercial release of any product in the medical industry. R&D activities are focused on achieving product design requirements, … Continue reading

Contact Details

Dr Brian Thomson
Director of Nottingham Health Science Biobank and Director of R&I
Email: | Tel: 0115 823 1832
Prof. Ian Ellis
Co-Director of Nottingham Health Science Biobank
Email: | Tel: 0115 969 1169 ext. 56875
Dr Balwir Matharoo-Ball
Operations Manager for Translational Research … Continue reading

2011 NUH R&D Annual Report published

This year’s annual report provides a summary of research activity at NUH during 2010/11, and describes progress against the NUH R&D Strategy. During this period NUH increased recruitment to NIHR portfolio clinical trials by 46%, ranking amongst the top six NHS Trusts in the country and increased research income from the NIHR and NIHR partners by 50%. Continue reading

PPI/E Useful Links

A national advisory group which supports greater public involvement in NHS, public health and social care research. INVOLVE provides a range of publications/guides for researchers, members of the public and commissioners.
INVOLVE: Briefing notes for researchers
A PDF guide
INVOLVE: People in Research
The … Continue reading

The Extended Biologic Study – The long-term Safety and Efficacy of Biologic Therapies in Children with Rheumatic Diseases

This study will document the use of “biologic drugs” in children with Juvenile Idiopathic Arthritis (JIA) to assess their benefit and safety. Examples of these drugs include etanercept, infliximab, adalimumab, anakinra, abatacept and rituximab. A blood or saliva sample from each child will also be stored for future studies (called a “BioBank”) to allow us to test whether there are variations in genes which can predict who will respond and who may get serious side effects. Until the emergence of biologic drugs, treatment options for severe JIA were limited to methotrexate (MTX) and steroids although many children failed to respond adequately or developed side effects. The new biologic drugs have revolutionised the treatment of JIA although they are not a cure and children need longterm treatment. Parents and children ask about side effects and whether or not the treatment will work for them the answer to such questions is currently lacking and the longterm risk of serious adverse events, such as infections or cancers is unknown. There has been a long track record of the use of biologic drugs in adults with rheumatoid arthritis. Increasingly these drugs are being used in children with arthritis. However, other than for the biologic drug etanercept, little information about their longterm effectiveness or safety in children exists. Following ethical approval, this study will follow children with JIA starting biologic drugs (other than etanercept) and record outcomes using data collected in routine clinical practice, such as improvement in arthritis, as well as serious side effects and compare these outcomes with those observed in a group of children receiving the nonbiologic drug, MTX. Access to clinical data and samples in the BioBank will be subject to rigorous security measures and will comply with national regulations for Good Clinical Practice.

Inclusion criteria:
Biologic Exposed cohort: 1. Patients either satisfying the revised ILAR classification criteria for Juvenile Idiopathic Arthritis (JIA) at the time of registration or diagnosed with JIA by the consultant rheumatologist 2. About to start therapy with a biologic drug, 3. Time from start of biologic agent to enrolment Exclusion criteria:
There are no specific exclusion criteria.

Principal Investigator for this trial: Dr Helen E Venning

Research Ethics Committee Reference: 09/H1008/137

Contact us about participating in this study by emailing R& or telephoning 0115 924 9924 Ext. 70076 Continue reading

Biomedical Research Units

Nottingham is home to two Biomedical Research Units (BRUs) awarded by the Department of Health. BRUs represent a large scale investment in infrastructure and promote a strong partnership between the NHS, academia and industry partners. This success have identified the … Continue reading

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