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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN30255103 |
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Date of registration:
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29/05/2008 |
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Primary sponsor: |
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Public title:
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Colon cancer detection by measuring DNA of cells collected from rectum: A pilot study
PTG (Pilot Trial Guildford) |
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Scientific title:
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Colorectal cancer screening by quantitative analysis of DNA isolated from exfoliated cells sampled from the surface of human rectal mucosa: A pilot study |
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Date of first enrolment:
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Apr 1 2005 |
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Target sample size:
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100-130 outpatients with unknown status and 50-60 patients with clinical diagnosis of colorectal cancer |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN30255103 |
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Study type:
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Observational |
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Study design:
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Observational pilot study
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Alexandre
Loktionov |
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Address:
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Colonix Medical Limited
Babraham Research Campus
Babraham
CB22 3AT
Cambridge
United Kingdom |
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Telephone:
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+44(0)1223 496095 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Two different groups of participants were recruited:
1. Consecutive outpatients presenting colorectal symptoms and selected for diagnostic full colonoscopy
2. Consecutive patients with clinical diagnosis of colorectal malignancies prepared for operations in the Royal Surrey County Hospital (Guildford)
Note: In this small pilot study there was no sex and age limitations. All patients were over 35 of age.
Exclusion criteria: Extensive surgical interventions in the colorectal region in the past
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Colorectal cancer; inflammatory bowel disease
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Intervention(s)
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This study was conducted with two distinct groups of participants:
1. Patients presenting colorectal symptoms (outpatient group)
2. Patients with clinical diagnosis of colorectal malignancies
This pilot study did not follow a "case-control" pattern; the two groups were enrolled for different purposes. The outpatient group provided samples for prospective analysis of DNA scores in individuals with a range of colorectal conditions. Investigation of the known cancer group addressed possible differences between tumours of the proximal and distal colon.
Interventions:
Samples of exfoliated cells were collected from the surface of rectal mucosa using proctoscopy and a short (10 sec) inflation in the rectal cavity of a cell-collecting balloon. The procedure was minimally invasive and was completed within five minutes. The collected samples were assessed for DNA contents.
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Primary Outcome(s)
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DNA yields from exfoliated materials (DNA scores) are assessed in terms of their predictive value in detecting the presence of serious colorectal conditions (colorectal cancer and inflammatory bowel disease)
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Secondary Outcome(s)
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No secondary outcome measures
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Source(s) of Monetary Support
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1. Colonix Medical Ltd (UK)
2. East of England Development Agency, Grant for Research and Development 2006 (UK)
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