Australian Barrett's Cohort With Dysplasia and Early Cancer Study

NCT02198976 | Recruiting DMC

• 1 other identifier: HREC2013/10/4.1 (3829)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect prospective observational data regarding endoscopic management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia and/or intramucosal carcinoma. To observe the natural history of patients with low grade dysplastic and non dysplastic Barrett's oesophagus

Conditions

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

• Number of Serious and Non-Serious Adverse Events

  Collect prospective observational data on patients undergoing endoluminal therapy for dysplastic BO to determine * Long term risk of oesophageal adenocarcinoma (OAC) development * Long term efficacy (dysplasia and metaplasia free) in both long and short segment BO * Short and long term safety and complications * Comparison of the safety, long term efficacy, cost and patient tolerability between endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) Document the endoscopic location and characterise morphology of HGD/IMC in short and long segment BO Define the short term and long term causes of morbidity / mortality of patients undergoing ER This will be recorded on a datasheet, de-identified during the procedure.

  During the Barretts Excision

Secondary Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events

  Up to 5 years after procedure

Study Arms (1)

Barrett's Oesophagus

Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus for removal.

You may qualify if:

• Can give informed consent to trial participation
• Age greater than 18
• Barrett's oesophagus

You may not qualify if:

• Age less than 18
• Pregnant patients

Sponsors & Collaborators

• Professor Michael Bourke: lead

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Michael J Bourke, MBBS

  Western Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bourke, MBBS

CONTACT

88905555; michael@citywestgastro.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastrointestinal Endoscopy

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 24, 2014
• Study Start: April 1, 2014
• Primary Completion (Estimated): May 1, 2034
• Study Completion (Estimated): November 1, 2034
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)