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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01372696




Trial ID
NCT01372696
Ethics application status
Date submitted
9/06/2011
Date registered
13/06/2011
Date last updated
14/11/2017

Titles & IDs
Public title
Endoscopic Characteristics of Colonic Tumours
Scientific title
A Correlation of the Endoscopic Characteristics of Colonic LSTs With Their Somatic or Germline Mutations. A Prospective, Genome Wide Study
Secondary ID [1] 0 0
LST-SGM
Universal Trial Number (UTN)
Trial acronym
C-LST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyp 0 0
Colon Cancer 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
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Sample of polyp

Other: Tissue sample - Patients who consent to participate in this study will have a small sample of their polyp and normal tissue sent for molecular testing.


Other interventions: Sample of polyp
A small sample of the colonic polyp will be obtained for molecular testing. The remaining polyp 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
Samples will be looked at and stored for approx 15 years

Eligibility
Key inclusion criteria
- Intention to perform Endoscopic Mucosal Resection

- Polyp 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
No limit
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 of the study
Other
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
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 colonoscopy, have formed
via different mutations and have different risks of turning into cancer.
Trial website
https://clinicaltrials.gov/show/NCT01372696
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke
Address 0 0
Westmead Hospital - Endoscopy Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Bourke
Address 0 0
Country 0 0
Phone 0 0
0298459779
Fax 0 0
Email 0 0
westmeadendoscopyresearch@gmail.com
Contact person for scientific queries