Condition category
Cancer
Date applied
02/03/2019
Date assigned
04/03/2019
Last edited
21/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Plain English summary under review with external organisation

Trial website

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

https://www.uhmb.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

21/06/2019: Internal review. 05/04/2019: Internal review. 04/03/2019: Trial's existence confirmed by Rosemere Cancer Foundation, Lancashire Teaching Hospitals NHS Foundation Trust and Royal Lancaster Infirmary.