Can neurotensin and IL-8 levels in blood be used to identify colorectal (large bowel) cancer and adenomas (polyps)?
ISRCTN | ISRCTN15709915 |
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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
Plain English summary of protocol
Contact information
Public
Furness General Hospital
Dalton Lane
Barrow-in-Furness
LA14 4LF
United Kingdom
0000-0002-7900-2003 | |
Phone | 01229 870870 |
georgios.sgourakis@elht.nhs.uk |
Study information
Study design | Multi-center case control study |
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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 |
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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
Burton Rd
Kendal
LA9 7RG
United Kingdom
Sharoe Green Ln
Fulwood
Preston
PR2 9HT
United Kingdom
Sponsor information
Hospital/treatment centre
Westmorland General Hospital
Burton Rd
Kendal
LA9 7RG
England
United Kingdom
Phone | 01229870870 |
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trusthq@mbht.nhs.uk | |
Website | https://www.uhmb.nhs.uk/ |
https://ror.org/05cxwhm03 |
Funders
Funder type
Charity
No information available
Results and Publications
Intention to publish date | 31/03/2025 |
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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
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.