Neurotensin and IL-8 for screening colorectal cancer and adenomas
Research type
Research Study
Full title
The combined use of serum Neurotensin and IL-8 as screening markers for colorectal cancer and adenomas. A prospective study.
IRAS ID
261217
Contact name
Georgios Sgourakis
Contact email
Sponsor organisation
University Hospitals of Morecambe Bay
ISRCTN Number
ISRCTN15709915
Clinicaltrials.gov Identifier
36415-CUFUP4, study ID ISRCTN15709915
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Neurotensin and Interleukin-8 for screening colorectal cancer and adenomas
Study questions the validity of the combined use of serum Neurotensin, and IL-8 as screening markers for colorectal adenomas and cancer.
Serum neurotensin and IL-8 values in the diagnosis of colorectal cancer have been reported for first time in the literature by the principal investigator in a published pilot study [Tumour Biol. 2014 Jun;35(6):5993-6002]. Potential benefit should be the re-definition of the cancer pathway and cost-effectiveness.
Individuals referred for colonoscopy under any indication after the application of the inclusion/exclusion criteria will be consented for giving a blood sample for Neurotensin and IL-8. Participants will then undergo colonoscopy and/or biopsies according to standard protocols.
Following the report of colonoscopy and the histology individuals will be assigned in three groups: a) group A - cancer patients, b) group B - adenoma patients and c) group C - No pathology/normal colonoscopy.
Two analyses will be conducted for Neurotensin and IL-8 for a) the diagnostic performance for cancer detection (group A versus group C) and b) the diagnostic performance for detection of adenomas (group B versus group C).
Inclusion criteria: Individuals over 50 years of age referred for colonoscopy under any indication.
Recruitment: Study will be conducted at Furness General Hospital and Royal Preston Hospital.
Patient Parameters: Age, Gender, BMI, Ethnicity, indication for colonoscopy, information concerning performance status, use of medications and Colonoscopic and histologic features.
The primary endpoints: the contribution of Neurotensin and IL-8 in the detection of colorectal cancer and colorectal adenomas. Secondary end points: comparison with the current screening program.
Sample size: We will require 500 patients in a 12 months’ period (interim report after first 250).
Funding Body: Rosemere Cancer Foundation.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
19/WM/0139
Date of REC Opinion
5 Sep 2019
REC opinion
Further Information Favourable Opinion