Contact information
Type
Public
Primary contact
Mr Georgios Sgourakis
ORCID ID
http://orcid.org/0000-0002-7900-2003
Contact details
Furness General Hospital
Dalton Lane
Barrow-in-Furness
LA14 4LF
United Kingdom
01229 870870
georgios.sgourakis@mbht.nhs.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
MB 909, IRAS 261217
Study information
Scientific title
The combined use of serum neurotensin and IL-8 as screening markers for colorectal cancer and adenomas. A prospective study.
Acronym
NIL
Study hypothesis
We have hypothesized that the combined use of serum neurotensin and IL-8 values has superior diagnostic performance than the established follow-up scheme for screening colorectal cancer and adenomas.
Ethics approval
Trial registration is required before ethics approval can be requested through IRAS.
Study design
Multi-center case control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Colorectal cancer/adenomas
Intervention
All individuals fulfilling the inclusion criteria will be enrolled. After the refinement of participants by the exclusion criteria, blood samples will be drawn for neurotensin and IL-8 testing by ELISA at Lancaster University, after being centrifuged and stored at deep freeze in -80°C in the Pathology Laboratories of Furness General Hospital and Royal Preston Hospital. Colonoscopy and histology reports will be obtained from Electronic patient Records (EPR). Following the report of the colonoscopy and histology departments, individuals will be assigned to one of three groups: group A - cancer patients, group B – adenoma (polyp) patients and group C – no pathology/normal colonoscopy. Two primary analyses will be conducted to define the cut-off plasma values for neurotensin and IL-8 for a) diagnosing cancer (group A versus group C) and b) diagnosing adenomas (group B versus group C). A secondary analysis will be conducted comparing the performance of the neurotensin/IL-8 system towards the 2-weeks referral and faecal occult blood (FOB) test-positive patients for the diagnosis of colorectal cancer and adenomas. There will be no observation or follow-up as part of the trial.
The reason for using participants without bowel pathology is because we need to define the normal range of neurotensin and IL-8 serum values.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Serum neurotensin measured by Human Neurotensin (NT) ELISA Kit (Cusabio)
2. Serum IL-8 values measured by ELISA (test brand tbc)
3. Diagnosis of colorectal cancer or adenoma using colonoscopy and histology reports
Secondary outcome measures
Diagnostic performance compared to the current screening system
Overall trial start date
01/09/2018
Overall trial end date
03/08/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 50 years
2. Referred for colonoscopy for any suspected indication
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
We are going to recruit 500 participants. An interim analysis will be conducted after the recruitment of 250.
Participant exclusion criteria
1. Need for emergency surgery
2. Presence of inflammatory bowel disease
3. Known history of inherited colorectal cancer
4. History of cancer in another primary site
5. Presence of liver metastases (since neurotensin is metabolized in the liver)
6. Negative previous colonoscopy for cancer
7. Haemolysis in serum samples
8. Informed consent not signed or patient withdrew consent
9. Persons who will not have the capacity to decide for themselves, who are unable to represent their own interests or are particularly susceptible to coercion
Recruitment start date
03/06/2019
Recruitment end date
03/06/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals of Morecambe Bay
Westmorland General Hospital
Burton Rd
Kendal
LA9 7RG
United Kingdom
Trial participating centre
Lancashire Teaching Hospitals Trust
Royal Preston Hospital
Sharoe Green Ln
Fulwood
Preston
PR2 9HT
United Kingdom
Sponsor information
Organisation
University Hospitals of Morecambe Bay
Sponsor details
Westmorland General Hospital
Burton Rd
Kendal
LA9 7RG
United Kingdom
01229870870
trusthq@mbht.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Rosemere Cancer Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be published in a peer-reviewed journal and will be also communicated to participants and GP practices.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available because the researchers have agreed to destroy electronic data relating to participants within 6 months of the last participant enrolment.
Intention to publish date
02/01/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list