Condition category
Cancer
Date applied
08/10/2010
Date assigned
24/02/2011
Last edited
08/09/2015
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 Matthew Brookes

ORCID ID

Contact details

Royal Wolverhampton NHS Trust
New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom
-
m.j.brookes@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9016

Study information

Scientific title

Is the tumour suppressor adenomatous polyposis coli (APC) crucial to iron mediated colorectal carcinogenesis? A single centre observational clinical laboratory study

Acronym

Study hypothesis

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

Black Country Research Ethics Committee, 03/08/2010, ref: 10/H1202/40

Study design

Single-centre non-randomised observational clinical laboratory study

Primary study design

Observational

Secondary study design

Non-randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2010

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 60 - 75 years, either sex
2. Bowel cancer screening patients attending for colonoscopy

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 90

Participant exclusion criteria

1. Unfit for colonoscopy
2. Previous colorectal cancer
3. Ongoing or previous cancer treatment (chemo-radiotherapy)

Recruitment start date

01/11/2010

Recruitment end date

01/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Wolverhampton NHS Trust, New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom

Sponsor information

Organisation

New Cross Hospital (UK)

Sponsor details

New Cross Hospital
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.royalwolverhamptonhospitals.nhs.uk/

Funders

Funder type

Charity

Funder name

Digestive Disorders Foundation (CORE) (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

Publication citations

Additional files

Editorial Notes