ClinicalTrials.gov
ClinicalTrials.gov Menu

Australian Barrett's Cohort With Dysplasia and Early Cancer Study (ABCDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02198976
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

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

Condition or disease
Barrett's Esophagus

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Australian Barrett's Cohort With Dysplasia and Early Cancer Study
Study Start Date : April 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

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



Primary Outcome Measures :
  1. Number of Serious and Non-Serious Adverse Events [ Time Frame: During the Barretts Excision ]

    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.


Secondary Outcome Measures :
  1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 5 years after procedure ]

    Establish the effect of endoluminal therapies for BO HGD/IMC on oesophageal motility. Document and grade the post EMR oesophageal defect and establish a possible link to subsequent complications (including stricture, bleeding and perforation) and recurrence. Perform cost-utility analyses comparing different treatment approaches for BO HGD/IMC, including EMR, RFA and oesophagectomy. Establish the relationship between Obstructive Sleep Apnea and BO. Understand patient attitudes and perceptions regarding BO, its treatment and its implication.

    Participants will be approached following their procedure and data recorded on a datasheet, this data will be linked to the initial procedure outcomes.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus for removal.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age less than 18
  • Pregnant patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198976


Contacts
Contact: Rebecca Sonson, BN 98455555 ext 59779 Rebecca.Sonson@health.nsw.gov.au
Contact: Farzan F Bahin, MBBS 98455555 ext 56700 farzan.fahrtash@sydney.edu.au

Locations
Australia, New South Wales
Westmead Endoscopy Unit Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Rebecca Sonson, BN    98455555 ext 59779    Rebecca.Sonson@health.nsw.gov.au   
Principal Investigator: Michael Bourke, MBBS         
Sub-Investigator: Farzan Bahin, MBBS         
Sponsors and Collaborators
Professor Michael Bourke
Investigators
Principal Investigator: Michael J Bourke, MBBS Western Sydney Local Health District

Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02198976     History of Changes
Other Study ID Numbers: HREC2013/10/4.1 (3829)
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases