Colon cancer detection by measuring DNA of cells collected from rectum: A pilot study
| ISRCTN | ISRCTN30255103 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30255103 |
| Secondary identifying numbers | PTG95-96 |
- Submission date
- 20/05/2008
- Registration date
- 29/05/2008
- Last edited
- 01/08/2012
- 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 Limited
Babraham Research Campus
Babraham
Cambridge
CB22 3AT
United Kingdom
| Phone | +44(0)1223 496095 |
|---|
Study information
| Study design | Observational pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Other |
| 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 pilot study |
| Study acronym | PTG (Pilot Trial Guildford) |
| 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 study closely related to this study has been registered with ISRCTN95403112 (http://www.controlled-trials.com/ISRCTN95403112) |
| Ethics approval(s) | South West Surrey Local Research Ethics Committee. Date of approval: 03/04/2004 (ref: 04/Q1909/38) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2005 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100-130 outpatients with unknown status and 50-60 patients with clinical diagnosis of colorectal cancer |
| Key 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. |
| Key exclusion criteria | Extensive surgical interventions in the colorectal region in the past |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Colonix Medical Limited
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
| Phone | +44(0)1223 496092 |
|---|---|
| alex.loktionov@colonixltd.co.uk | |
| Website | http://www.colonixmedical.com |
"ROR" |
https://ror.org/01g15q926 |
Funders
Funder type
Industry
Colonix Medical Ltd (UK)
No information available
East of England Development Agency, Grant for Research and Development 2006 (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 | 01/02/2009 | Yes | No |
