Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PTG95-96
Study information
Scientific title
Colorectal cancer screening by quantitative analysis of DNA isolated from exfoliated cells sampled from the surface of human rectal mucosa: A pilot study
Acronym
PTG (Pilot Trial Guildford)
Study hypothesis
Cell exfoliation from the surface of colorectal tumours is much more intensive than from normal colorectal mucosa. The hypothesis is that exfoliated cells are transferred to the rectum within mucocellular layer separating colon mucosa from the gut contents, and accumulation of exfoliated cells in cancer patients is much greater comparing to healthy individuals. It is suggested that this phenomenon can be used for colorectal cancer early detection and screening.
Please note that another study closely related to this study has been registered with ISRCTN95403112 (http://www.controlled-trials.com/ISRCTN95403112)
Ethics approval
South West Surrey Local Research Ethics Committee. Date of approval: 03/04/2004 (ref: 04/Q1909/38)
Study design
Observational pilot study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Other
Trial type
Screening
Patient information sheet
Condition
Colorectal cancer; inflammatory bowel disease
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/04/2005
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100-130 outpatients with unknown status and 50-60 patients with clinical diagnosis of colorectal cancer
Participant exclusion criteria
Extensive surgical interventions in the colorectal region in the past
Recruitment start date
01/04/2005
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Colonix Medical Limited
Cambridge
CB22 3AT
United Kingdom
Sponsor information
Organisation
Colonix Medical Ltd (UK)
Sponsor details
Babraham Research Campus
Babraham
Cambridge
CB22 3AT
United Kingdom
+44(0)1223 496092
alex.loktionov@colonixltd.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Colonix Medical Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
East of England Development Agency, Grant for Research and Development 2006 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19148463
Publication citations
-
Results
Loktionov A, Bandaletova T, Llewelyn AH, Dion C, Lywood HG, Lywood RC, Rockall TA, Stebbing JF, Broughton M, Caffarey S, Marks CG, Colorectal cancer detection by measuring DNA from exfoliated colonocytes obtained by direct contact with rectal mucosa., Int. J. Oncol., 2009, 34, 2, 301-311.