Condition category
Cancer
Date applied
20/05/2008
Date assigned
29/05/2008
Last edited
01/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexandre Loktionov

ORCID ID

Contact details

Colonix Medical Limited
Babraham Research Campus
Babraham
Cambridge
CB22 3AT
United Kingdom
+44(0)1223 496095

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 measures

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

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

http://www.colonixmedical.com

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19148463

Publication citations

  1. 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.

Additional files

Editorial Notes