Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03471793




Registration number
NCT03471793
Ethics application status
Date submitted
13/03/2018
Date registered
21/03/2018
Date last updated
29/06/2023

Titles & IDs
Public title
The Australian Colonic Large Sessile Lesion Endoscopic Resection Study
Scientific title
The Australian Colonic Large Sessile Lesion Endoscopic Resection Study
Secondary ID [1] 0 0
HREC/16/WMEAD/383(4831)
Universal Trial Number (UTN)
Trial acronym
ACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon Adenoma 0 0
Colon Polyp 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Colonic polyp - Patients referred for EMR of a colonic polyp >20mm
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence
Timepoint [1] 0 0
6-60months
Secondary outcome [1] 0 0
Technical success for Endoscopic resection
Timepoint [1] 0 0
6-60 months
Secondary outcome [2] 0 0
Cancer prediction
Timepoint [2] 0 0
peri-procedurally

Eligibility
Key inclusion criteria
- Patients referred for endoscopic resection of a large sessile colonic polyp or
laterally spreading tumour =20mm in size.

- Able to give informed consent to involvement in the clinical study
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to provide informed consent for involvement

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
24/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2037
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A prospective, multicentre, observational study of all patients referred for endoscopic
resection of sessile colorectal polyps sized =20 mm conducted with intention to treat
analysis
Trial website
https://clinicaltrials.gov/ct2/show/NCT03471793
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03471793