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OpenTrials
Completed

NCT Number: NCT01556399

Endoscopic Characteristics of Duodenal and Ampullary Lesions

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tissue Sampling

Other

A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Official study title

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

Acronym: DUO/AMP-LST

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Mar 16, 2012
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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