Saliva to predict risk of disease using transcriptomics and epigenetics

Not Applicable

• Conditions: Oesophageal cancer, colorectal cancer, Crohn's disease; Cancer

• Registration Number: ISRCTN11921553
• Lead Sponsor: niversity College London

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32150588/ results (added 25/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-04
• Last Update Posted: 7 September 2021
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Current participant inclusion criteria as of 25/08/2021:
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.

For patients with Crohn's disease, both the UK IBD Bioresource and participating centres will contact patients inviting them to sign up for the study online.

Previous 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.

Exclusion Criteria

Current participant exclusion criteria as of 25/08/2021:
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 18 years

Previous 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epigenetic and transcriptomic biomarkers, measured using next generation sequencing of saliva/blood/tissue samples collected at single study visit

Secondary Outcome Measures

Name	Time	Method
Disease symptoms and risk factors, measured using questionnaire at single study visit