Wnt signalling in colon cancer
| ISRCTN | ISRCTN37721571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37721571 |
| Secondary identifying numbers | 9016 |
- Submission date
- 08/10/2010
- Registration date
- 24/02/2011
- Last edited
- 18/12/2017
- 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 Matthew Brookes
Scientific
Scientific
Royal Wolverhampton NHS Trust, New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom
| m.j.brookes@bham.ac.uk |
Study information
| Study design | Single-centre non-randomised observational clinical laboratory study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non-randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Is the tumour suppressor adenomatous polyposis coli (APC) crucial to iron mediated colorectal carcinogenesis? A single centre observational clinical laboratory study |
| Study objectives | Hypothesis and proof of concept: Our hypothesis is that increase in cellular iron import proteins (TfR1, DMT1) occur early in the adenoma-carcinoma sequence through mutations in APC and lead to cellular iron loading. As demonstrated in our previous work the effects of this iron loading is to mediate increased Wnt signalling resulting in c-myc induction. This in turn serves to increase the expression of iron import proteins (TfR1, DMT1) and decrease the expression of iron export (ferroportin [FPN]) and storage (ferritin) proteins. Such a hypothesis explains how Wnt signalling controls iron metabolism and ensures that there is adequate cellular iron for ATP generation and cellular proliferation. Experimental design: To test such a hypothesis we aim to prospectively collect the following colorectal tissue from patients attending for colonoscopy: 1. Normal colonic mucosa in patients with no colorectal pathology (n = 30) 2. Polyps and matched normal colon (n = 30) 3. Colorectal cancers and matched normal colon (n = 30) We also intend to collect serum and urine from the following patient groups: 4. Normal colonoscopy (n = 30) 5. Colorectal adenomas (n = 30) 6. Colorectal cancers (n = 30) |
| Ethics approval(s) | Black Country Research Ethics Committee, 03/08/2010, ref: 10/H1202/40 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon |
| Intervention | This will include the collection of tissue from normal colonic tissue, adenomatous polyps and colorectal cancers. Alongside this we will collect serum and urine to measure systemic iron transport proteins. Following collection of tissue we will determine the expression of APC and the cellular iron transport proteins utilising techniques including, mass spectrometry, western blotting, Real-Time PCR and immunohistochemistry. In each group of patients (normal, polyps or colorectal cancer) we will determine the expression of the iron transport proteins and determine if there are significant changes demonstrable. Follow Up Length: 12 month(s); Study Entry : Registration only |
| Intervention type | Other |
| Primary outcome measure | Measured at baseline, using the expression of proteins in the tissue and serum to detect the cellular and systemic iron transport proteins. The techniques used will include mass spectrometry, western blotting, real time PCR and immunohistochemistry. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/11/2010 |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned sample size: 90 |
| Key inclusion criteria | 1. Aged between 60 - 75 years, either sex 2. Bowel cancer screening patients attending for colonoscopy |
| Key exclusion criteria | 1. Unfit for colonoscopy 2. Previous colorectal cancer 3. Ongoing or previous cancer treatment (chemo-radiotherapy) |
| Date of first enrolment | 01/11/2010 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Wolverhampton NHS Trust, New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom
WV10 0QP
United Kingdom
Sponsor information
New Cross Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
New Cross Hospital
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
England
United Kingdom
| Website | http://www.royalwolverhamptonhospitals.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/05w3e4z48 |
Funders
Funder type
Charity
Digestive Disorders Foundation (CORE) (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 | 30/08/2012 | Yes | No |
Editorial Notes
18/12/2017: Publication reference added.
