None listed
Conditions
Brief summary
This study aims to determine if a panel of salivary biomarkers could assist in the diagnosis of Barrett's oesophagus and its pathological variants, dysplasia and oesophageal adenocarcinoma. You may be eligible for this study if you are an adult male or female referred for investigation of reflux symptoms or other suspected gastrointestinal disease, as well as patients with established Barrett’s oesophagus and/or suspected or established oesophageal adenocarcinoma. Any patient with one of the Barrett's related conditions or random healthy patients who may undergo an endoscopy for another indication, maybe approached to consider participation in this study. Participants will be asked to contribute samples of saliva, blood and gastric fluid before undergoing an endoscopic procedure. This study aims to determine if a panel of salivary biomarkers could assist in the diagnosis of Barrett's oesophagus and its pathological variants, dysplasia and oesophageal adenocarcinoma. You may be eligible for this study if you are an adult male or female referred for investigation of reflux symptoms or other suspected gastrointestinal disease, as well as patients with established Barrett’s oesophagus and/or suspected or established oesophageal adenocarcinoma. Any patient with one of the Barrett's related conditions or random healthy patients who may undergo an endoscopy for another indication, maybe approached to consider participation in this study. Participants will be asked to contribute samples of saliva, blood and gastric fluid before undergoing their usual endoscopic procedure. It is hoped that findings from this study will help to develop a simple non-invasive saliva test to screen for oesophageal cancer.
Interventions
This is an exploratory study to evaluate potential proteomic markers in salivary samples. This is novel and is seeking to determine if a panel of salivary biomarkers could assist in the diagnosis of Barrett's oesophagus and its pathological variants, dysplasia and oesophageal adenocarcinoma. Samples (saliva, blood, gastric secretions) will be collected at standard-care encounters. Samples will be collected by a trained research nurse. At each standard-care encounter participants will be asked to
This is an exploratory study to evaluate potential proteomic markers in salivary samples. This is novel and is seeking to determine if a panel of salivary biomarkers could assist in the diagnosis of Barrett's oesophagus and its pathological variants, dysplasia and oesophageal adenocarcinoma. Samples (saliva, blood, gastric secretions) will be collected at standard-care encounters. Samples will be collected by a trained research nurse. At each standard-care encounter participants will be asked to contribute blood samples (20-40mls), saliva samples and gastric fluid from your usual endoscopy procedure. A 'healthy' control group (a) will be compared to other risk-stratified sub-groups of Barrett's neoplasia. (b) Non-dysplastic Barrett's Oesophagus (BO) group (n=50) – patients with current Barrett's Oesophagus (BO) but without evidence or history of Barrett’s-dysplasia, undergoing endoscopy (c) Dysplastic BO group (n=50) – patients with current BO and either low-grade or high-grade dysplasia, undergoing endoscopy (d) Early Oesophageal Adenocarcinoma (OAC) group (n=50) – patients with current BO and evidence of early OAC, undergoing endoscopy (e) Advanced OAC group (n=50) – patients with current BO and advanced OAC, undergoing either endoscopy, surgery, or non-operative treatment for this
Sponsors
Royal Brisbane & Women's Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
• Referral for investigation of reflux symptoms or other suspected gastrointestinal disease, as well as patients with established Barrett’s oesophagus and/or suspected or established oesophageal adenocarcinoma • Age between 18 and 100 years old • Willingness to participate for the duration of the trial period • Provision of written Informed Consent for participation in this study
Exclusion criteria
• Patients medically unsuitable for further testing or oesophageal screening, as determined by the treating clinician. • High risk of poor compliance to participate with study requirements or follow-up as assessed by the investigator • Current illness that will interfere with the collection of saliva, gastric secretions and/or blood samples • Previous invasive malignancy within 5 years of current diagnosis with the exception of skin cancer other than melanoma. • Previous cancer treatment in the last 5 years.
Outcome results
None listed