Condition category
Cancer
Date applied
08/07/2008
Date assigned
16/07/2008
Last edited
31/07/2012
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 Ltd
Babraham Research Campus
Babraham
Cambridge
CB22 3AT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VTD/PTO 06

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 case-control study

Acronym

VTD/PTO

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 trial closely related to this study has been registered with ISRCTN30255103 (http://www.controlled-trials.com/ISRCTN30255103)

Ethics approval

1. Oxford Research Ethics Committee. Date of approval: 15/02/2006 (ref: 06/Q1605/21)
2. South West Surrey Local Research Ethics Committee. Date of approval: 12/04/2006 (Amendment 4 to ref: 04/Q1909/38)

Study design

Observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Colorectal cancer

Intervention

This study was conducted with two distinct groups of participants:
1. Patients with clinical diagnosis of colorectal malignancies
2. Clinically healthy volunteers

In this case-control study both cancer patients and healthy volunteers provided samples for the analysis of DNA scores.

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 colorectal cancer

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2006

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Case group: Consecutive patients (both males and females) with clinical diagnosis of colorectal malignancies recruited by Colorectal Surgery Department of the John Radcliffe Hospital (Oxford, UK)
2. Control group: Clinically healthy volunteers (both males and females), age 50-70, recruited by Honiton Hospital (Honiton, UK)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100-110 healthy controls and 50-60 patients with clinical diagnosis of colorectal cancer

Participant exclusion criteria

1. For both case and control groups: Extensive surgical interventions in the colorectal region or colorectal malignancies in the past
2. For control group: Chronic colorectal conditions (even asymptomatic)

Recruitment start date

01/05/2006

Recruitment end date

01/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Colonix Medical Ltd
Cambridge
CB22 3AT
United Kingdom

Sponsor information

Organisation

Colonix Medical Ltd (UK)

Sponsor details

Babraham Research Campus
Babraham
Cambridge
CB22 3AT
United Kingdom
enquiries@colonixmedical.com

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

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19588499

Publication citations

  1. Results

    Loktionov A, Ferrett CG, Gibson JJ, Bandaletova T, Dion C, Llewelyn AH, Lywood HG, Lywood RC, George BD, Mortensen NJ, A case-control study of colorectal cancer detection by quantification of DNA isolated from directly collected exfoliated colonocytes., Int. J. Cancer, 2010, 126, 8, 1910-1919, doi: 10.1002/ijc.24729.

Additional files

Editorial Notes