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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Western Sydney Local Health District
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01556399
First received: March 15, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 Intervention
Duodenal Diseases
Other: Tissue Sampling

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Western Sydney Local Health District:

Primary Outcome Measures:
  • Significant differences in molecular abnormalities. [ Time Frame: Specimens will be stored and used for up to 15 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 350
Study Start Date: November 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556399

Contacts
Contact: Michael Bourke, MBBS, FRACP 0409042019 bec2153@gmail.com
Contact: Rebecca Sonson, BM 98459779 bec2153@gmail.com

Locations
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael Bourke, MBBS, FRACP    0409042019    bec2153@gmail.com   
Contact: Rebecca Sonson, BN    98459779    bec2153@gmail.com   
Sponsors and Collaborators
Professor Michael Bourke
Investigators
Principal Investigator: Michael Bourke, MBBS, FRACP Western Sydney Local Health District
  More Information

No publications provided

Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01556399     History of Changes
Other Study ID Numbers: LST-UGIM
Study First Received: March 15, 2012
Last Updated: June 30, 2014
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Western Sydney Local Health District:
Duodenal adenoma
Ampullary adenoma

Additional relevant MeSH terms:
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014