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Trial registered on ANZCTR


Registration number
ACTRN12621001057875
Ethics application status
Approved
Date submitted
17/06/2021
Date registered
11/08/2021
Date last updated
11/08/2021
Date data sharing statement initially provided
11/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and Participant acceptability of use of the UriSWAB™ collection system
Scientific title
Feasibility and Participant acceptability of use of the UriSWAB™ collection system in individuals attending smoking cessation and respiratory medicine clinics.
Secondary ID [1] 304383 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nicotine addiction 322176 0
cigarette smoking 322812 0
Condition category
Condition code
Respiratory 319862 319862 0 0
Other respiratory disorders / diseases
Mental Health 320399 320399 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will recruit 20 current smokers and/or e-cigarette users and/or people using nicotine replacement therapy that attend smoking cessation clinics, outpatient clinics or in-patient wards. Potential participants will be asked if they are interested to participate in the observational study, in person whilst in clinic.
The clinicians in clinic will identify smokers or those using nicotine replacement therapy or eCigs based on clinical assessment (standard of care).
Each potential participant will be offered a patient information sheet and consent form telling them about the study. They will have an opportunity to accept invitation on the day, or next time they present to clinic.

Relevant demographic data will be recorded. Medical History, smoking variables and current medications will also be recorded. Patient demographic and clinical data will be collected from patients electronic or paper based medical records using a structured data collection form, the case report form (CRF).

On the day of clinic (in either an outpatient or inpatient setting) an exhaled Carbon Monoxide reading will be collected (standard of care), and the ppt will be asked to provide a urine sample in a standard urine sample container and a UriSWAB™ sample. This collection of samples will be collected contemporaneously.
Intervention code [1] 320747 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327738 0
Participant reported acceptability of the use of the UriSWAB™ collection system measured via a feedback form using a 5 point Likert scale and free text comments.
Timepoint [1] 327738 0
completed on the day of specimen collection
Primary outcome [2] 328233 0
Feasibility of the UriSWAB™ system as a collection method capable of detecting nicotine metabolites when delivered via standard postage methods (samples are delivered intact and on time - audit of delivery times via postal service database, and integrity of collection tube via laboratory logs)
Timepoint [2] 328233 0
within a week of sample collection
Primary outcome [3] 328249 0
comparison of Nicotine metabolite measurements using Ultraperformance Liquid Chromatography between paired samples ( UriSWAB™ samples compared to samples collected according to standard pathology methods).
Timepoint [3] 328249 0
4 weeks post sample collection
Secondary outcome [1] 398260 0
nil
Timepoint [1] 398260 0
nil

Eligibility
Key inclusion criteria
• >/= 18 years old
• Current or former smoker using Nicotine Replacement Therapy (NRT) and or e-cigarettes
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient refusal

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In this descriptive study, the effect on an intervention is not being tested against a comparator arm and so a traditional sample size calculation is not possible. However, we estimate the sample size required at around 10% of the number required for a statistically powered study.

Recruitment
Recruitment status
Not yet recruiting
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)
QLD
Recruitment hospital [1] 19608 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 19609 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 34244 0
4032 - Chermside
Recruitment postcode(s) [2] 34245 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 308753 0
University
Name [1] 308753 0
The University of Queensland
Address [1] 308753 0
St Lucia
Brisbane, Qld
4067
Country [1] 308753 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
Brisbane, Qld
4067
Country
Australia
Secondary sponsor category [1] 309654 0
None
Name [1] 309654 0
None
Address [1] 309654 0
None
Country [1] 309654 0
Other collaborator category [1] 281852 0
Hospital
Name [1] 281852 0
Metro North Hospital and Health Service
Address [1] 281852 0
Level 2, Admin Building
Rode Rd
Chermside, Qld, 4032
Country [1] 281852 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308671 0
The Prince Charles Hospital Health Research Ethics Committee
Ethics committee address [1] 308671 0
The Prince Charles Hospital
Building 14
Rode Rd Chermside Qld
4032
Ethics committee country [1] 308671 0
Australia
Date submitted for ethics approval [1] 308671 0
06/05/2021
Approval date [1] 308671 0
15/06/2021
Ethics approval number [1] 308671 0
HREC/2021/QPCH/75583

Summary
Brief summary
Biochemical validation is the gold standard of measuring smoking abstinence in smoking cessation clinical trials. It increases scientific rigor, however, feasibility of sample collection and stability of samples before testing can be a drawback in clinical trials. This study has the potential to establish acceptability of a novel urine collection method, and to test the feasibility of remote sample collection and stability of urine samples using the UriSWAB™ over time. If effective, this method will allow remote biochemical validation of smoking abstinence, which will be useful in larger scale smoking cessation clinical trials in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111502 0
A/Prof Henry Marshall
Address 111502 0
Level 2 Admin Building
University of Qld Thoracic Research Centre
The Prince Charles Hospital
627 Rode Rd
Chermside, Qld
4032
Country 111502 0
Australia
Phone 111502 0
+61731394000
Fax 111502 0
Email 111502 0
henry.marshall@health.qld.gov.au
Contact person for public queries
Name 111503 0
Ms Jenny Peek
Address 111503 0
Level 2 Admin Building
University of Qld Thoracic Research Centre
The Prince Charles Hospital
627 Rode Rd
Chermside, Qld
4032
Country 111503 0
Australia
Phone 111503 0
+61731396802
Fax 111503 0
Email 111503 0
jenny.peek@health.qld.gov.au
Contact person for scientific queries
Name 111504 0
A/Prof Henry Marshall
Address 111504 0
Level 2 Admin Building
University of Qld Thoracic Research Centre
The Prince Charles Hospital
627 Rode Rd
Chermside, Qld
4032
Country 111504 0
Australia
Phone 111504 0
+61 73139 4000
Fax 111504 0
Email 111504 0
henry.marshall@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
upon completion of recruitment and analysis and manuscript publication by our research team, available for 5 years after publication.
Available to whom?
Bona fide research teams with appropriate HREC approvals and subject to University of Queensland ratification
Available for what types of analyses?
any purpose
How or where can data be obtained?
upon request subject to approvals by Principal Investigator and other details as above (quit.research@health.qld.gov.au).
What supporting documents are/will be available?
No other documents available
Summary results
No Results