JUNE 2008
In this Issue

UK randomizes its first patient in TEAM and Dr Marco Stefani from the Federal University of Rio Grande do Sul, Porto Alegro, Brazil, got National acceptance (CONEP) as well as a special budget (FINEP) for participating in TEAM. Read details in Update on recruitment, below.

Welcome message
Welcome to the first edition of the TEAM monthly eNewsletter!

We are very proud to welcome you to this first issue of the monthly TEAM study eNewsletter, a resource for the TEAM investigator’s community. Our goal is to keep you regularly informed of the study progress.

It will feature some the following topics:

• Editorial (We will be presenting views of TEAM investigators and coordinators as well as some special interventions from ethicians, neuropsychologists, neurologists, etc…)

• The latest updates on recruitment from the Clinical Trial Office

• Frequently Asked Questions regarding the study conduct, forms and processes

• Regulatory and ethical considerations

• Upcoming events

• Other exciting research news and events

We are eager to learn about your thoughts and comments, so your feedback will be greatly appreciated. If you have any questions regarding the content of this newsletter, wish to collaborate with some writing, have any suggestions or requests, please contact The Clinical Trials Office at guylaine.gevry@crchum.qc.ca

We hope you find this newsletter interesting! We have put our hearts on it!

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Editorial
A TEAM participant Testimony

We have the immense pride and pleasure to introduce our very first recruited patient in TEAM. She is honouring us here with a testimony that voices the feelings and hardships that all patients with a recent discovered aneurysm go through, and the reason why she ended up choosing TEAM as her best option so far.

Hello,
When I learned that I had an asymptomatic unruptured brain aneurysm, ofabout 1 cm, I tried to understand.

I searched around and eventually found myself welcomed by a team of neuroradiologists specialized in a non-invasive treatment that we call endovascular.

I asked lots of questions of which the last one was: Is it absolutely necessary to operate or intervene? And I received the answer… the honest response: “We do not know it”. I couldn’t believe my ears. I would not be told with certitude if it was better to intervene, with all the risks involved, nor if it was better not to do it at all.

Through some personal research, I also found out that there are plenty of carriers of unruptured aneurysms who ignore they have them. But myself, I had a decision to make. It was my life that was in risk and unfortunately, the present situation of medical knowledge couldn’t help providing an answer for me. It was then, that I was proposed to participate in the research project TEAM.

I meditated about it, weighted the pros and cons, and nothing was inclining me to favour one option rather than the other. Do we intervene or do we leave it alone? So, I cut it short. Chance on a randomized trial will choose for me. With this choice, at least I had ONE certitude. I will be participating in the search of a future answer.

Soon, when someone like me turns out with an unruptured aneurysm, we will be able to tell this person, with complete authority: YES or NO… and we have a trial to support it.

TEAM participating patient

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Update on recruitment
UK Randomizes their first patient in TEAM

UK randomizes their first patient! Congratulations to Dr Tufail F. Patankar and co-ordinator Stephen Duberley from the Royal Preston Hospital, Lancashire Teaching Hospitals NHS Trust.

Congratulation also to Dr Marco Stefani. He obtained national approval in Brazil as well as a special fund. This means that the study in Porto Alegre will be sponsored by a Brazilian Governmental Institution and the costs will be covered outside the public health care system throught a specific budget created for the trial. Dr Stefani will also present TEAM at the Brazilian Society of Neurosurgery meeting next September. Keep up the good work. Centre participation now stands at 38, with several more expected to go “live” this summer. At press time, CHUM Notre-Dame Hospital leads in enrollments with a total of 16 patients followed by CHU Côte-de-Nacre, Caen, France (Pr Patrick Courthéoux and Dre Suzana Saleme) with 7 patients recruited. Québec Enfant-Jésus Hospital (Dre Geneviève Milot) recruited 5 patients, Hôpital Lariboisière, Paris (Pr Emmanuel Houdart), 3 patients, while Hôpital Purpan, Toulouse (Pr Christophe Cognard), CHU Nancy, Nancy (Pr Serge Bracard), Hôpital Gabriel-Montpied, Clermont-Ferrand (Pr Emmanuel Chabert), Hôpital Neurologique et Neurochirurgical, Lyon (Pr Francis Turjman and Dre Florence Tahon), Hospital Universitari de Bellvitge, Barcelona (Dre Maria-Angeles De Miquel) as well as Royal Preston Hospital, Preston (Dr Tufail Pantakar and Stephen Duberley) tied at one patient each.

We also want to sincerely acknowledge and thank all of you who have attempted to enroll patients. Your efforts are vital to TEAM and we are gratified by your perseverance.

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Gen-TEAM:
Genome-wide Study of Aneurysmal Rupture: an ancillary study to the TEAM trial

Working together with Jean Raymond and his team, W.L. Young and H. Kim at the University of California - San Francisco Center for Cerebrovascular Research (UCSF CCR) have developed a grant proposal to the National Institutes of Health (US) titled “Genome-wide Study of Aneurysmal Rupture: an ancillary study to the TEAM trial” or Gen-TEAM. Gen-TEAM will be a genome-wide association study to identify novel genetic biomarkers for SAH in patients harboring intracranial aneurysms; it will be conducted in collaboration with the network of TEAM investigators who would have assembled a unique clinical research infrastructure for the study of intracranial aneurysms.

The first Gen-TEAM application was submitted to the National Institutes of Health in the fall of 2007. Although the grant was not funded, the first set of reviews provided a number of addressable criticisms, and a revised application will be submitted in the fall of 2008. For the first submission, one third of all TEAM investigators responded to a survey indicating their enthusiasm for the project. We, at the TEAM headquarters, are hoping that a response rate of near 100% will be achieved for the planned resubmission. You will soon receive by email a request for support of Gen-TEAM, the terms of which have been fully indorsed by the TEAM Steering Committee. Please, take the time to consider the merits of Gen-TEAM and, if you judge this research effort to be worthwhile, please express your support by responding to their email or contact them directly at: YoungW@Anesthesia.ucsf.edu

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News and Events
LINNC: Live Interventional Neuroradiology and Neurosurgery Course, Paris.

Tuesday June 17, 2008:
Is there an alternative to evidence based medicine? What is the real scientific value of a Registry for devices? Presented by Jean Raymond

Aims and Results of registries on aneurysms: Atena, Clarity, CCT, Helps, TEAM. Presented by Christophe Cognard, Jean Raymond, Laurent Pierot and Laurent Spelle

Followed by a round table: How do we manage and use Trials.

Recent Publications:
Raymond J, Guillemin F, Proust F, Molyneux AJ, Fox A, Johnston SC, Meder JF, Rouleau I. The Trial on Endovascular Aneurysm Management (TEAM) collaborative group. Unruptured intracranial aneurysms: A critical review of available studies and of appropriate methods to address the clinical problem. Interventional Neuroradiology. 2008 March;14(1): 85-96.

Raymond J, Roy D, Weill A, Guilbert F, Nguyen T, Molyneux AJ, Fox AJ, Johnston SC, Cognard C, Pierot L, Meder JF, Rouleau I; Trial on Endovascular Aneurysm Management (TEAM) collaborative group. Unruptured intracranial aneurysms: Their illusive natural history and why subgroup statistics cannot provide normative criteria for clinical decisions or selection criteria for a randomized trial. J Neuroradiol. 2008 Jan 31. [Epub ahead of print]

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Contact us
We are there for you...

and do not forget to consult the web site. All study documents are in the professional area. We also have some promotional material ready to be distributed (mainly in french, english and spanish) but we can provide you with material needed in your langage, just contact us!

Head Office
NRI-Clinical Research Unit
CHUM Hôpital Notre-Dame
1560 Sherbrooke est
Pavillon Simard, suite Z12909
Montréal, CANADA H2L 4M1
Tél: +1 514 890 8000
Fax: +1 514 412 7621
Guylaine Gevry extension 27235
Ruby Klink extension 25245
Marcia Loor extension 26359

TEAM Europe Coordination Centre
Oxford Neurovascular & Neuroradiology
Research Unit
John Radcliffe Hospital
Level 6, The West Wing
Headley Way
Oxford 0X3 9DU
Tel:+44 (0) 1865 234755
Fax: +44 (0) 1865 234757
Julia Yarnold

TEAM France Coordination Centre
CHU de Reims - Hôpital Maison-Blanche
CRICAM
51092 REIMS Cedex
Tel: +33 3 26 78 92 65
Fax: +33 3 26 78 88 39
Béatrice Domissy-Baury

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