Endoscopic Characteristics of Duodenal and Ampullary Lesions (DUO/AMP-LST)

March 25, 2025 updated by: Professor Michael Bourke

A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.

The purpose is to investigate whether polyps that look different at endoscopy, have formed via different mutations and have different risks of turning into cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Laterally spreading tumours (LSTs), are polyps that have a lateral extension along the duodenal wall with minimal vertical growth. It has become evident over the last few years that rather than being a single entity requiring an accumulation of mutations, Duodenal and ampullary cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. It is therefore hypothesised that different polyp types have different genetic abnormalities, and potentially form via distinct genetic pathways, although this theory has not been widely examined.

This knowledge would be important in furthering our understanding of the development of cancer. There is accumulating evidence that genetic abnormalities may be a better predictor of cancer behaviour than histological grade. Additionally, guidelines for endoscopy surveillance are currently a one size fits all approach that do not reflect the genetic heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer. Genetic studies may assess future cancer risk to a person in polyps once removed and plan surveillance endoscopy frequency.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Duodenal and/or ampullary adenomas or cancers.

Description

Inclusion Criteria:

  • Intention to perform Endoscopic Mucosal Resection
  • Adenoma equal to or greater than 20mm
  • over 18 years of age
  • Able to give informed consent to involvement in trial

Exclusion Criteria:

  • Pregnancy
  • Lactation: currently breastfeeding
  • Taken clopidogrel within 7 days
  • Taken warfarin within 5 days
  • Had full therapeutic dose unfractionated heparin within 6 hours
  • Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
  • Known clotting disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Duodenal adenomas
Patients who consent to participate in this study will have a small sample of their adenoma and normal tissue sent for molecular testing.
Other: Tissue Sampling
A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant differences in molecular abnormalities.
Time Frame: Specimens will be stored and used for up to 15 years
The aim of this project is to look for statistically significant differences in molecular abnormalities from the three known genetic pathways, between the two different morphological types, granular and non-granular, to potentially demonstrate that these different polyps form via different genetic pathways.
Specimens will be stored and used for up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Michael Bourke

Investigators

  • Principal Investigator: Michael Bourke, MBBS, FRACP, Western Sydney Local Health District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimated)

March 16, 2012

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LST-UGIM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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