Can neurotensin and IL-8 levels in blood be used to identify colorectal (large bowel) cancer and adenomas (polyps)?

ISRCTN	ISRCTN15709915
DOI	https://doi.org/10.1186/ISRCTN15709915
IRAS number	261217
Secondary identifying numbers	MB 909, IRAS 261217

Submission date: 02/03/2019
Registration date: 04/03/2019
Last edited: 08/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-develop-a-screening-test-for-bowel-cancer-nil

Contact information

Mr Georgios Sgourakis
Public

Furness General Hospital
Dalton Lane
Barrow-in-Furness
LA14 4LF
United Kingdom

ORCID ID	0000-0002-7900-2003
Phone	01229 870870
Email	georgios.sgourakis@elht.nhs.uk

Study information

Study design	Multi-center case control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	The combined use of serum neurotensin and IL-8 as screening markers for colorectal cancer and adenomas. A prospective study.
Study acronym	NIL
Study objectives	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(s)	Trial registration is required before ethics approval can be requested through IRAS.
Health condition(s) or problem(s) studied	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
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 study start date	01/09/2018
Completion date	30/12/2024

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	We are going to recruit 500 participants. An interim analysis will be conducted after the recruitment of 250.
Key inclusion criteria	1. Aged over 50 years 2. Referred for colonoscopy for any suspected indication
Key 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
Date of first enrolment	03/06/2019
Date of final enrolment	30/11/2024

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

University Hospitals of Morecambe Bay

Westmorland General Hospital
Burton Rd
Kendal
LA9 7RG
United Kingdom

Lancashire Teaching Hospitals Trust

Royal Preston Hospital
Sharoe Green Ln
Fulwood
Preston
PR2 9HT
United Kingdom

Sponsor information

University Hospitals of Morecambe Bay
Hospital/treatment centre

Westmorland General Hospital
Burton Rd
Kendal
LA9 7RG
England
United Kingdom

Phone	01229870870
Email	trusthq@mbht.nhs.uk
Website	https://www.uhmb.nhs.uk/
"ROR"	https://ror.org/05cxwhm03

Funders

Funder type

Charity

Rosemere Cancer Foundation

No information available

Results and Publications

Intention to publish date	31/03/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 0.5	16/02/2019	18/10/2022	No	No

Additional files

ISRCTN15709915_Protocol_V0.5_16Feb2019.pdf

Editorial Notes

08/09/2023: The following changes have been made:
1. The overall study end date has been changed from 03/08/2021 to 30/12/2024.
2. The recruitment end date has been changed from 03/06/2020 to 30/11/2024.
04/09/2023: The intention to publish date was changed from 03/08/2022 to 31/03/2025.
18/10/2022: Protocol file uploaded.
01/02/2022: Cancer Research UK plain English summary link added to plain English summary field.
13/07/2020: The following changes were made to the trial record:
1. The overall end date was changed from 03/08/2020 to 03/08/2021.
2. The intention to publish date was changed from 02/01/2021 to 03/08/2022.
29/04/2020: The trial contact has been updated.
05/08/2019: Internal review.
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.