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ISRCTN
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ISRCTN80827145
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ClinicalTrials.gov identifier
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Public title
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A randomised, double blind trial to assess the morphological and biological effects with Arimidex, compared to placebo when used as neoadjuvant treatment for patients with endometrial cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0436125539
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Study hypothesis
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To investigate the therapeutic effects of Arimidex in endometrial cancer. Primary objective - to assess the volume of endometrial cancer in both the Arimidex and placebo arm, and to compare the biology of the endometrial cancer in both arms.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised placebo controlled parallel group trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Endometrial cancer
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Participants - inclusion criteria
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Patients for this study will be recruited form a number of selected gynaecology/oncology units in the Yorkshire Strategic Health Authority. No formal power calculation is possible as there is no information or literature in this research. An arbitrary figure of 60 patients has been chosen based on 30% accrual from the patient population. Currently 203 patients per year are registered in the Yorkshire region. Of these, 84%b undergo surgery (n = 170) and therefore eligible to participate. In order to produce more information on the Arimimdex arm the patients will be randomised on a 2:1 basis to either Arimidex or placebo.
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Participants - exclusion criteria
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170
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Anticipated start date
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01/04/2003
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Anticipated end date
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31/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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170
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Interventions
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Randomised controlled trial. Random allocation to [A] Arimidex [B] placebo
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Primary outcome measure(s)
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1. Alteration in endometrial cancer volume as determined by MRI
2. Alteration in immumohistochemical markers of proliferation and apoptosis
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Secondary outcome measure(s)
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1. Incidence of side effects
2. Number of lymph node positive cases at surgical staging
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Sources of funding
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Leeds Teaching Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
S R
Duffy
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Address
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Level 9
Gledhow Wing
St James's University Hospital
Beckett Street
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City/town
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Leeds
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Zip/Postcode
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LS9 7TF
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Country
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United Kingdom
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Tel
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+44 (0)113 206 5840
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Fax
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+44(0)113 206 6220
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Email
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s.r.duffy@leeds.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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12/08/2009
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Date ISRCTN assigned
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30/09/2004
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