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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01372696
Ethics application status
Date submitted
9/06/2011
Date registered
14/06/2011
Date last updated
3/07/2023

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.
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
Sex
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
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
0
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01372696