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ISRCTN
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ISRCTN76694943
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ClinicalTrials.gov identifier
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Public title
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A multicentre trial to evaluate the use of serial carcinoembryonic antigen (CEA) assay as the prime indicator for second-look surgery in recurrent colorectal 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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CRCGICEA
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Study hypothesis
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Not provided at time of registration
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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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Colon, rectum
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Participants - inclusion criteria
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1. Aged 75 or under
2. Potentially curative resection performed for colorectal adenocarcinoma
3. No evidence of distant incurable spread (clinically or at surgery)
4. No evidence of hepatic, renal, pancreatic or infective disease
5. Willing to attend regular CEA monitoring in addition to clinical follow-up for 5 years
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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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01/01/1998
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Anticipated end date
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31/12/2000
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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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All patients receive primary potentially curative surgery. Patients are randomised if a significant rise in serum CEA is detected to either:
1. Conventional Arm: Observation only. The patient is monitored until there is clinical evidence of recurrent disease. The clinician is not informed of the rise in serum CEA.
2. Aggressive Arm : The surgeon is informed of the rise in serum CEA, and in the absence of objective evidence either of a non-malignant cause for the CEA rise or of incurable distant metastases, second-look laparotomy is carried out to locate and remove treatable recurrence.
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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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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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13/05/2008
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Date ISRCTN assigned
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01/07/2001
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