An observational study in Duodenal Diseases, sponsored by Professor Michael Bourke. Completed at 1 site in Australia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Professor Michael Bourke · Observational
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.
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.
Professor Michael Bourke is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Duodenal and/or ampullary adenomas or cancers.
Exclusion Criteria:
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.
Significant differences in molecular abnormalities.
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.
Time frame: Specimens will be stored and used for up to 15 years
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Duodenal Diseases
Professor Michael Bourke