Colon cancer detection by measuring DNA of cells collected from rectum: A case-control study
| ISRCTN | ISRCTN95403112 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95403112 |
| Secondary identifying numbers | VTD/PTO 06 |
- Submission date
- 08/07/2008
- Registration date
- 16/07/2008
- Last edited
- 31/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alexandre Loktionov
Scientific
Scientific
Colonix Medical Ltd
Babraham Research Campus
Babraham
Cambridge
CB22 3AT
United Kingdom
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Not specified |
| Study type | Screening |
| 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 |
| Study acronym | VTD/PTO |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2006 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100-110 healthy controls and 50-60 patients with clinical diagnosis of colorectal cancer |
| Key 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) |
| Key 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) |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Colonix Medical Ltd
Cambridge
CB22 3AT
United Kingdom
CB22 3AT
United Kingdom
Sponsor information
Colonix Medical Ltd (UK)
Industry
Industry
Babraham Research Campus
Babraham
Cambridge
CB22 3AT
United Kingdom
| enquiries@colonixmedical.com | |
| Website | http://www.colonixmedical.com |
"ROR" |
https://ror.org/01g15q926 |
Funders
Funder type
Industry
Colonix Medical Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/04/2010 | Yes | No |
