Condition category
Cancer
Date applied
15/09/2017
Date assigned
04/10/2017
Last edited
20/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
University College London (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

Contact information

Type

Scientific

Primary contact

Prof Laurence Lovat

ORCID ID

Contact details

UCL
Wing 2.4 Cruciform Building
Gower Street
London
WC1E 6BT
United Kingdom

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 measures

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

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

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Rosetrees Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes