DUO/AMP-LST: Endoscopic Characteristics of Duodenal and Ampullary Lesions
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Significant differences in molecular abnormalities. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Intention to perform Endoscopic Mucosal Resection
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Adenoma equal to or greater than 20mm
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over 18 years of age
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Able to give informed consent to involvement in trial
Exclusion Criteria:
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Pregnancy
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Lactation: currently breastfeeding
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Taken clopidogrel within 7 days
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Taken warfarin within 5 days
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Had full therapeutic dose unfractionated heparin within 6 hours
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Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
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Known clotting disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Westmead Hospital | Westmead | New South Wales | Australia | 2145 |
Sponsors and Collaborators
- Professor Michael Bourke
Investigators
- Principal Investigator: Michael Bourke, MBBS, FRACP, Western Sydney Local Health District
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LST-UGIM