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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 261217 |
| Protocol serial number | MB 909, IRAS 261217 |
| Sponsor | University Hospitals of Morecambe Bay |
| Funder | Rosemere Cancer Foundation |
- 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
 ORCID ID |
0000-0002-7900-2003 |
|---|---|
| Phone | 01229 870870 |
| georgios.sgourakis@elht.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-center case control study |
| Secondary study design | Case-control study |
| Study type | 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(s) |
1. Serum neurotensin measured by Human Neurotensin (NT) ELISA Kit (Cusabio) |
| Key secondary outcome measure(s) |
Diagnostic performance compared to the current screening system |
| Completion date | 30/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 500 |
| 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
- United Kingdom
- England
Study participating centres
Burton Rd
Kendal
LA9 7RG
United Kingdom
Sharoe Green Ln
Fulwood
Preston
PR2 9HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 0.5 | 16/02/2019 | 18/10/2022 | No | No |
Additional files
- ISRCTN15709915_Protocol_V0.5_16Feb2019.pdf
- Protocol file
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.
