Duodenal DiseasesDUO/AMP-LSTNCT01556399
Endoscopic Characteristics of Duodenal and Ampullary Lesions
An observational study of Duodenal Diseases, run by Professor Michael Bourke at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Duodenal Diseases
- What is being tested?
- Tissue Sampling
- How many people
- 350 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2011to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Duodenal and/or ampullary adenomas or cancers.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.
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.
Read the 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.
- Conditions
- Duodenal Diseases
- Being tested
- Tissue Sampling
- Keywords
- Duodenal adenoma, Ampullary adenoma
- Medical subject headings
- Duodenal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue SamplingOther
A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tissue Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Specimens will be stored and used for up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Michael Bourke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael Bourke, MBBS, FRACP, Principal investigator, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556399
- Sponsor's protocol ID
- LST-UGIM
- Acronym
- DUO/AMP-LST
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2012
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.
- ClinicalTrials.gov ID
- NCT01556399
- Acronym / sponsor ID
- DUO/AMP-LST / LST-UGIM
- Conditions
- Duodenal Diseases
- Keywords
- Duodenal adenoma, Ampullary adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duodenal adenomas | – | Other: Tissue SamplingPatients who consent to participate in this study will have a small sample of their adenoma and normal tissue sent for molecular testing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Duodenal and/or ampullary adenomas or cancers.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation: currently breastfeeding
- Taken clopidogrel within 7 days
- Taken warfarin within 5 days
- Had full therapeutic dose unfractionated heparin within 6 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue SamplingA small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing. | Other | Duodenal adenomas |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bourke, MBBS, FRACP principal investigator
Western Sydney Local Health District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duodenal Diseases, run by Professor Michael Bourke at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant differences in molecular abnormalities. (time frame: Specimens will be stored and used for up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.