Endoscopic Characteristics of Duodenal and Ampullary Lesions

Duodenal Diseases Clinical Trial

— DUO/AMP-LST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556399
• Other study ID #: LST-UGIM
• Status: Completed
• Start date: November 2011
• Est. completion date: November 2018

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Duodenal Diseases

Intervention

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.

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Specimens will be stored and used for up to 15 years