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
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|Condition or disease||Intervention/treatment|
|Duodenal Diseases||Other: Tissue Sampling|
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 Type :||Observational|
|Estimated Enrollment :||350 participants|
|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|
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.
- 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
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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|
- 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
- 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
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
|Contact: Michael Bourke, MBBS, FRACPemail@example.com|
|Contact: Iddo Bar-Yishay, MDfirstname.lastname@example.org|
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Contact: Michael Bourke, MBBS, FRACP 0409042019 email@example.com|
|Contact: Iddo Bar-Yishay, MD 89905555 firstname.lastname@example.org|
|Principal Investigator:||Michael Bourke, MBBS, FRACP||Western Sydney Local Health District|
|Responsible Party:||Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District|
|Other Study ID Numbers:||
|First Posted:||March 16, 2012 Key Record Dates|
|Last Update Posted:||March 23, 2021|
|Last Verified:||March 2021|
Digestive System Diseases