Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000805279
Ethics application status
Approved
Date submitted
11/09/2009
Date registered
16/09/2009
Date last updated
18/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational, multicentre, non interventional programme to register patients diagnosed with neuroendocrine tumours (NETs) and monitor their patterns of care in Australian hospitals.
Scientific title
Neuroendocrine Tumour Non-interventional Patient Registry to monitor patterns of care in Australian Hospitals
Secondary ID [1] 252759 0
SIGNETURe
Universal Trial Number (UTN)
Trial acronym
SIGNETURe (Specialist Interest Group in Neuroendocrine Tumours Unique Registry)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Tumours 243818 0
Condition category
Condition code
Cancer 239990 239990 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non-interventional. This study will capture how patients are treated in current clinical practice. There will be no change to current clinical practice. The duration of the study is open-ended but analyses will be ongoing throughout the study period.
Intervention code [1] 241258 0
Not applicable
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240891 0
To assess patterns of care in Australian Hospitals.
A web-based database that will capture information obtained from medical records. The information will be used to assess the outcomes (disease progression rates/survival rates) in patients with neuroendocrine tumours and correlate this with the treatment regimens received.
Timepoint [1] 240891 0
Not defined. Data will be analysed on a periodic basis.
Secondary outcome [1] 257565 0
Incidence and Prevalence of Neuroendocrine Tumours in Australia. Web-based database will be able to record the number of patients in Australia with this disease, record the diagnosis rate of new patients and additional demographic information such as age, sex and race.
Timepoint [1] 257565 0
Not defined. Data will be analysed on a periodic basis.

Eligibility
Key inclusion criteria
Diagnosis of Neuroendocrine Tumour.
Informed Consent Given.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2071 0
5000
Recruitment postcode(s) [2] 2105 0
2217
Recruitment postcode(s) [3] 2106 0
2065
Recruitment postcode(s) [4] 2107 0
5011

Funding & Sponsors
Funding source category [1] 243717 0
Commercial sector/Industry
Name [1] 243717 0
Ipsen Pty Ltd
Country [1] 243717 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian NET Specialist Interest Group
Address
C/- Dr Tim Price
Queen Elizabeth Hospital
28 Woodville Road
Woodville, SA 5011
Country
Australia
Secondary sponsor category [1] 237080 0
None
Name [1] 237080 0
Address [1] 237080 0
Country [1] 237080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243844 0
Royal Adelaide Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 243844 0
Ethics committee country [1] 243844 0
Australia
Date submitted for ethics approval [1] 243844 0
Approval date [1] 243844 0
26/08/2009
Ethics approval number [1] 243844 0
090811

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30271 0
Address 30271 0
Country 30271 0
Phone 30271 0
Fax 30271 0
Email 30271 0
Contact person for public queries
Name 13518 0
Angela Gibbs
Address 13518 0
Ipsen Pty Ltd
PO Box 820
Glen Waverley
Victoria 3150
Country 13518 0
Australia
Phone 13518 0
+61 38544 8100
Fax 13518 0
+61 99562 5152
Email 13518 0
Angela Gibbs
Contact person for scientific queries
Name 4446 0
Dr Monica de Abadal
Address 4446 0
Ipsen Pty Ltd
PO Box 820
Glen Waverley
Victoria 3150
Country 4446 0
Australia
Phone 4446 0
+61 38544 8100
Fax 4446 0
+61 9562 5152
Email 4446 0
monica.deabadal@ipsen.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.