Plain English Summary
Background and study aims
There are numerous lifestyle-altering diseases in the UK for which patients undergo multiple invasive tests before they can be properly diagnosed. These tests are often uncomfortable and inconvenient for patients, in addition to being very costly for the National Health Service (NHS). They typically involve a degree of risk to patients (e.g. bleeding and bowel rupture during endoscopy, or harmful radiation exposure from CT scanning). Many of these tests also tend to have normal results, since only a small fraction of patients are eventually diagnosed with the disease being sought. The aim of this study is to analyse symptoms, risk factors and genetic changes detected in saliva samples to predict patients’ risk of developing diseases.
Who can participate?
Patients aged over 21 who are already known to have oesophageal or colorectal disease, and patients who are awaiting tests to diagnose or exclude the disease
What does the study involve?
Participants complete a questionnaire to obtain information regarding their symptoms and risk factors for the disease. Saliva and blood samples are collected and, when appropriate, tissue samples are taken during any investigations that they are already scheduled to undergo as part of their treatment process. No additional procedures or interventions are performed on these patients, and their clinical treatment is not affected in any way. Genetic analysis is performed on these samples to see if the characteristics of the patients’ saliva in combination with symptoms and other risk factors can accurately predict their disease. The saliva test results are compared with the blood and, where possible, tissue test results.
What are the possible benefits and risks of participating?
The results may help to create a cheap, portable and quick bedside test that uses patients’ saliva to predict their risk of disease, so that only high-risk patients will in future need to undergo invasive investigations. This will save the NHS and other healthcare systems worldwide significant amounts of money, while saving patients across the world time, inconvenience and reducing their risk of complications from unnecessary investigations.
Where is the study run from?
1. University College London (UK)
2. University College London Hospitals NHS Trust (UK)
3. Guy's and St Thomas' NHS Foundation Trust (UK)
4. Lister Hospital (UK)
5. Frimley Park Hospital (UK)
6. Wexham Park Hospital (UK)
7. Western Sussex Hospitals NHS Foundation Trust (UK)
8. Princess Alexandra Hospital (UK)
9. Royal Albert Edward Infirmary (UK)
10. Royal Surrey County Hospital (UK)
11. Shrewsbury and Telford Hospital NHS Trust (UK)
When is the study starting and how long is it expected to run for?
April 2017 to October 2019
Who is funding the study?
1. Rosetrees Trust (UK)
2. CORE Digestive Disorders Foundation (UK)
Who is the main contact?
Prof. Laurence Lovat
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRAS 217388
Study information
Scientific title
Saliva to predict risk of disease using transcriptomics and epigenetics (SPIT): an observational study
Acronym
SPIT
Study hypothesis
There are numerous lifestyle-altering diseases in the UK for which patients undergo multiple invasive tests before they can be properly diagnosed. These tests are often uncomfortable and inconvenient for patients, in addition to being very costly for the National Health Service (NHS). They typically involve a degree of risk to patients (e.g. bleeding and bowel rupture during endoscopy; or harmful radiation exposure from CT scanning). Many of these tests also tend to have normal results, since only a small fraction of patients are eventually diagnosed with the disease being sought. This study will focus on using analysis of symptoms, risk factors and genetic changes detected in saliva samples to predict patients’ risk of developing diseases.
Ethics approval
West Midlands - Coventry & Warwickshire Research Ethics Committee, 28/02/2017, ref: 17/WM/0079
Study design
Observational basic science 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 the contact details to request a patient information sheet
Condition
Oesophageal cancer, colorectal cancer
Intervention
A ‘symptom and risk factor’ questionnaire will be developed based on known symptoms and risk factors for the disease being studied. Saliva will be collected from patients from the identified groups representing the disease profiles being studied and appropriate control subjects and analysed for epigenetic and transcriptomic biomarkers. Matched blood samples may also be collected from patients to demonstrate whether the salivary epigenetic and transcriptomic findings match those in the blood. Where patients are already undergoing invasive tests, matched tissue samples from normal and diseased tissue may be collected to demonstrate whether the salivary epigenetic and transcriptomic findings match those in the tissue. Bioinformatics combined with novel artificial intelligence techniques will be used to analyse the samples to identify highly accurate biomarker profiles to predict the presence of both disease and disease risk.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Epigenetic and transcriptomic biomarkers, measured using next generation sequencing of saliva/blood/tissue samples collected at single study visit
Secondary outcome measures
Disease symptoms and risk factors, measured using questionnaire at single study visit
Overall trial start date
06/04/2017
Overall trial end date
01/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
For the initial study of oesophageal disease, both current and new patients identified as having oesophageal disease (e.g. Barrett’s oesophagus, oesophageal cancer) will be recruited together with those being referred along the 2-week-wait cancer-target pathway. Patients without oesophageal disease attending for a clinically indicated endoscopy may be recruited as controls.
For the initial study of colorectal disease, patients will be recruited from the National Bowel Cancer Screening Programme, as well as from other patients with colorectal disease attending for colonoscopy. Patients without colorectal disease attending for a clinically indicated colonoscopy may be recruited as controls.
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
2000
Participant exclusion criteria
1. Patients who are unable to undergo definitive investigations such as colonoscopy or surgery as a definitive pathological diagnosis will not be achievable in such instances
2. Patients who are unable to give informed consent in English, or in the presence of an English translator
3. Pregnant women
4. Patients under the age of 21 years
Recruitment start date
06/04/2017
Recruitment end date
01/08/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
WC1E 6BT
United Kingdom
Trial participating centre
University College London Hospitals NHS Trust
NW1 2PG
United Kingdom
Trial participating centre
Guy's and St Thomas' NHS Foundation Trust
SE1 9RT
United Kingdom
Trial participating centre
Lister Hospital
SW1W 8RH
United Kingdom
Trial participating centre
Frimley Park Hospital
GU16 7UJ
United Kingdom
Trial participating centre
Wexham Park Hospital
SL2 4HL
United Kingdom
Trial participating centre
Western Sussex Hospitals NHS Foundation Trust
BN11 2DH
United Kingdom
Trial participating centre
Princess Alexandra Hospital
CM20 1QX
United Kingdom
Trial participating centre
Royal Albert Edward Infirmary
WN1 2NN
United Kingdom
Trial participating centre
Royal Surrey County Hospital
GU2 7XX
United Kingdom
Trial participating centre
Shrewsbury and Telford Hospital NHS Trust
SY3 8XQ
United Kingdom
Funders
Funder type
Charity
Funder name
Rosetrees Trust
Alternative name(s)
Teresa Rosenbaum Golden Charitable Trust, Rosetrees
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Funder name
CORE Digestive Disorders Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Laurence Lovat. Data will be available after the study ends.
Intention to publish date
01/10/2020
Participant level data
Available on request
Basic results (scientific)
Publication list