Endoscopic Characteristics of Duodenal and Ampullary Lesions
DUO/AMP-LST
A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.
1 other identifier
observational
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 15, 2012
CompletedFirst Posted
Study publicly available on registry
March 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedMarch 27, 2025
March 1, 2025
6 years
March 15, 2012
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.
Eligibility Criteria
Patients with Duodenal and/or ampullary adenomas or cancers.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Biospecimen
Adenoma tissue sample and control "regular" tissue sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bourke, MBBS, FRACP
Western Sydney Local Health District
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Gastrointestinal Endoscopy
Study Record Dates
First Submitted
March 15, 2012
First Posted
March 16, 2012
Study Start
November 1, 2011
Primary Completion
November 1, 2017
Study Completion
November 1, 2018
Last Updated
March 27, 2025
Record last verified: 2025-03