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Endoscopic Characteristics of Duodenal and Ampullary Lesions (DUO/AMP-LST)

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ClinicalTrials.gov Identifier: NCT01556399
Recruitment Status : Unknown
Verified March 2021 by Professor Michael Bourke, Western Sydney Local Health District.
Recruitment status was:  Recruiting
First Posted : March 16, 2012
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

Study Description
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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
Duodenal Diseases Other: Tissue Sampling

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
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.
Study Start Date : November 2011
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Group/Cohort 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.


Outcome Measures
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Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Adenoma tissue sample and control "regular" tissue sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Duodenal and/or ampullary adenomas or cancers.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556399


Contacts
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Contact: Michael Bourke, MBBS, FRACP 0409042019 kathleen.goodrick@health.nsw.gov.au
Contact: Iddo Bar-Yishay, MD 89905555 iddo.baryishay@health.nsw.gov.au

Locations
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Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael Bourke, MBBS, FRACP    0409042019    kathleen.goodrick@health.nsw.gov.au   
Contact: Iddo Bar-Yishay, MD    89905555    iddo.baryishay@health.nsw.gov.au   
Sponsors and Collaborators
Professor Michael Bourke
Investigators
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Principal Investigator: Michael Bourke, MBBS, FRACP Western Sydney Local Health District
More Information
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Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01556399    
Other Study ID Numbers: LST-UGIM
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Keywords provided by Professor Michael Bourke, Western Sydney Local Health District:
Duodenal adenoma
Ampullary adenoma
Additional relevant MeSH terms:
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Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases