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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01556399




Registration number
NCT01556399
Ethics application status
Date submitted
15/03/2012
Date registered
16/03/2012
Date last updated
26/02/2019

Titles & IDs
Public title
Endoscopic Characteristics of Duodenal and Ampullary Lesions
Scientific title
A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.
Secondary ID [1] 0 0
LST-UGIM
Universal Trial Number (UTN)
Trial acronym
DUO/AMP-LST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Duodenal Diseases 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Tissue Sampling

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 interventions: 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Specimens will be stored and used for up to 15 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01556399
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, MBBS, FRACP
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Bourke, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
0409042019
Fax 0 0
Email 0 0
bec2153@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01556399