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ISRCTN
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ISRCTN61091474
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial to assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent - pilot study
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Scientific title
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Acronym
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FACS (Follow-up After Colorectal Surgery)
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Serial number at source
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HTA 99/10/09
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Study hypothesis
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Aim: To assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent.
Objectives:
1. To confirm the feasibility of recruiting 5000 participants from 20 centres to the trial in two years.
2. To assess the effectiveness and cost-effectiveness of serial blood CEA measurement in detecting treatable recurrence and thereby improving 5 year survival.
3. To assess the effectiveness and cost-effectiveness of hospital follow-up involving regular ultrasound and CT imaging compared with no imaging and follow-up in general practice in detecting treatable recurrence and thereby improving 5 year survival.
Details of this study can also be found at: http://www.hta.ac.uk/1229
The ISRCTN record of main FACS trial that followed this pilot study can be found at: http://www.controlled-trials.com/ISRCTN41458548.
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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 controlled 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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Cancer (neoplasms): Rectum; Cancer (neoplasms): Colon
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Participants - inclusion criteria
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Patients who have undergone resection for colorectal cancer with curative intent.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/09/2002
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Anticipated end date
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29/02/2004
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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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Not provided at time of registration.
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Interventions
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Monitoring of carcinoembryonic antigen (CEA) in primary care vs intensive imaging in hospital.
Follow-up after 3 months.
See details of ISRCTN41458548: FACS main trial on http://www.controlled-trials.com/isrctn/trial/ISRCTN41458548/0/41458548.html
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Primary outcome measure(s)
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Not provided at time of registration.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.facs.soton.ac.uk/
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Publications
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No publication intended as of 06/10/2009
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Contact name
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Prof
John
Primrose
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Address
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School of Medicine
University of Southampton
Biomedical Sciences Building
Bassett Crescent East
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Tel
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+44 2380 796144
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Fax
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+44 2380 794020
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Email
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j.n.primrose@soton.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)1132 545 843
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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09/10/2009
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Date ISRCTN assigned
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25/04/2003
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