Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000325707
Ethics application status
Approved
Date submitted
29/11/2012
Date registered
25/03/2013
Date last updated
19/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Waitemata Community Wellness Biobank: analysis of stored biological samples to evaluate health outcomes and plan public health strategies
Scientific title
Waitemata Community Wellness Biobank: analysis of stored biological samples to evaluate health outcomes and plan public health strategies
Secondary ID [1] 281603 0
Nil
Universal Trial Number (UTN)
U1111-1137-4472
Trial acronym
NSH Biobank
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 288676 0
Diabetes 288677 0
Obesity and metabolic disease 288678 0
Gastrointestinal cancer 288679 0
Condition category
Condition code
Cardiovascular 288261 288261 0 0
Diseases of the vasculature and circulation including the lymphatic system
Diet and Nutrition 288262 288262 0 0
Obesity
Metabolic and Endocrine 288263 288263 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observation of the exposure of an individual to current medical standard of care e.g. current medicines etc and environmental exposure e.g. diet and smoking. This exposure will be compared with long-term health outcomes using electronic medical records and coded DRGs. Genomic DNA from whole blood and plasma will be stored on patients. Genomic, proteomic and metabolomic analysis will be applied to the samples to assess interactions between the individual, drugs and environment. Data will also be aggregated from electronic clinical records and patient questionnaires. The patient questionnaire will be completed at the beginning of the study and will not be repeated. Blood samples will be collected at 6mths, 1, 2, 3, 5 and 10 year periods.
Intervention code [1] 286138 0
Not applicable
Comparator / control treatment
The historical control will be the baseline results for the same patient if the patient represents to hospital or clinic and has further blood drawn. Alternatively the historical control will be patients treated in the past with older treatment practices.
Control group
Historical

Outcomes
Primary outcome [1] 288439 0
Incidence of cardiovascular disease as assessed using data linkage to electronic medical records
Timepoint [1] 288439 0
6 months, 12 months, 2 years, 3 years, 5 years, 10 years. Participants will not necessarily be recalled. Outcomes will be assessed using electronic medical records.
Secondary outcome [1] 300169 0
Incidence of diabetes complications and control using the HBA1C assay
Timepoint [1] 300169 0
6mths, 12mths, 2yrs, 3yrs, 5yrs, 10yrs
Secondary outcome [2] 301856 0
Incidence of gastrointestinal cancer assessed through colonoscopy results in electronic medical records, and ICD10 diagnosis codes.
Timepoint [2] 301856 0
6mths, 12mths, 2yrs, 3yrs, 5yrs, 10yrs
Secondary outcome [3] 301915 0
Incidence of inflammatory bowel disease using inflammatory markers, patient diary and/or electronic medical records.
Timepoint [3] 301915 0
6mths, 12mths, 2yrs. 3yrs, 5yrs, 10yrs

Eligibility
Key inclusion criteria
Patients presenting to hospital via ambulatory clinics or the emergency department. Community patients from primary care will also be included.
Minimum age
16 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
5/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment outside Australia
Country [1] 4697 0
New Zealand
State/province [1] 4697 0

Funding & Sponsors
Funding source category [1] 286413 0
Commercial sector/Industry
Name [1] 286413 0
Theranostics Lab
Country [1] 286413 0
New Zealand
Primary sponsor type
Hospital
Name
North Shore hospital
Address
124 Shakespeare Rd, Westlake 0622, New Zealand
Country
New Zealand
Secondary sponsor category [1] 285196 0
Charities/Societies/Foundations
Name [1] 285196 0
New Zealand Institute of Clinical Excellence
Address [1] 285196 0
North Shore hospital clinical laboratory,
Shakespeare Rd,
Takapuna,
Auckland 0622
Country [1] 285196 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288489 0
Northern A Regional Ethics Committee
Ethics committee address [1] 288489 0
Ethics committee country [1] 288489 0
New Zealand
Date submitted for ethics approval [1] 288489 0
04/12/2012
Approval date [1] 288489 0
01/04/2015
Ethics approval number [1] 288489 0

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

Contacts
Principal investigator
Name 34997 0
Dr Patrick A. Gladding
Address 34997 0
26 Volcanic St,
Mt. Eden,
Auckland 1041
Country 34997 0
New Zealand
Phone 34997 0
+64220424325
Fax 34997 0
Email 34997 0
patrickg@theranosticslab.com
Contact person for public queries
Name 18244 0
Patrick A. Gladding
Address 18244 0
26 Volcanic St,
Mt Eden
Auckland 1041
Country 18244 0
New Zealand
Phone 18244 0
+64220424325
Fax 18244 0
Email 18244 0
patrickg@theranosticslab.com
Contact person for scientific queries
Name 9172 0
Patrick Gladding
Address 9172 0
26 Volcanic St,
Mt Eden
Auckland 1041
Country 9172 0
New Zealand
Phone 9172 0
+64220424325
Fax 9172 0
Email 9172 0
patrickg@theranosticslab.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.