ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000769785

Ethics application status

Approved

Date submitted

9/07/2013

Date registered

10/07/2013

Date last updated

11/02/2019

Date data sharing statement initially provided

11/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluation of pathology tests using alternative sample collection methods

Scientific title

A comparison of pathology test results using alternative sample collection methods vs standard methods

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1145-4329

Trial acronym

DBS Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

This study will compare the accuracy of alternative sample collection methods for measuring substances in the blood, urine or saliva of volunteers.

Condition category

Condition code

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Participants will be asked to come in to a collection centre. They may be asked to fast for a minimum 12-hour fast in the morning. Participants may be be recontacted by our team, and would undergo the same procedures (venous blood collection, capillary blood collection, urine collection and/or saliva collection), not less than 6 weeks before the previous collection. A single session will last up to 60 minutes.

The Clinical Nurse will explain the study procedures (as per Information Sheet) and will obtain written informed consent.

Study procedures and data collection will include:

i) Medical history questionnaire: a code will be assigned to each participant. The Clinical Research Nurse will complete a brief medical history questionnaire, including date of birth, gender, past/previous medical history, and past/previous use of medications.
ii) Fasting: Participants may be advised not to consume food, alcohol or caffeine for 12 hours prior to the collection. They will also be advised that they can consume water during the fasting period. Prior to collection, participants will be asked to confirm when they last ate or consumed alcohol or caffeine: no risks associated.
iii) Venous blood collection: Venous blood will be collected from an arm vein by the Clinical Research Nurse following standard sterile techniques. The maximum amount of blood that will be collected will be about 50 ml (approximately 1/10 of a blood donation), drawn into appropriate tubes for analysis. The tubes with blood will be kept on ice for transportation to the pathology lab. Minimal physical risks associated with drawing venous blood are pain, bruising or bleeding at the time the needle is inserted. Serious adverse effects are blood clot or infection, but they are very rare. Some subjects may faint during the procedure. Those risks will be minimised by using careful sterile techniques, with the patients sitting comfortably on a chair. If bruising occurs, ice cubes or cold packs will be placed over the area for a few seconds, followed by the placement of a cotton pad and bandage over the site. If fainting occurs, needle will be removed and the participant will lie down and/or raise the feet for a minute or two. After resting for five to ten minutes, if the participant is feeling well and vital signs are normal, the participant can continue on as normal.
iv) Capillary blood collection: Capillary blood will be collected from a finger prick by the participant under the guidance of the Clinical Research Nurse following standard sterile techniques. The maximum amount of blood that will be collected will be 40ul (0.04ml) in 8 blood spots on purpose specific cellulose filter paper. The filter paper will be placed into a breathable envelope for transportation to the pathology lab. The blood spots will dry during transportation. Minimal physical risks associated with collecting capillary blood are minor pain, bruising or bleeding at the time the finger is lanced. A serious adverse effect could be infection, but this is very rare. Those risks will be minimised by using careful sterile techniques, with the patients sitting comfortably on a chair. A sterile safety lancet will be used to prick the finger.

After venous blood collection, capillary blood samples will be collected by the participant onto the filter paper, as per instructions provided at the collection.

v)Saliva and urine collection: Participants will be guided to self-collect saliva samples. Approximately 2 ml of saliva will be collected per test into a 2ml tube/saliva collection device using the passive drool method or using a saliva oral swab. Participants will be given a sterile, leakproof urine collection container, and instructed to collect up to 50 ml of urine from midstream, in a bathroom.
Venous blood samples, urine and/or saliva will be transported to the pathology lab at the end of each morning by the Research Nurse. Dried blood spot samples collected onto the filter papers will be provided to the Pathology Lab.

Samples will be analysed in duplicates.

Intervention code [1]

Not applicable

Comparator / control treatment

Lab results obtained from new sample collection methods (eg. dried blood spot) will be compared to those obtained from standard methods (eg. venous blood)

Control group

Active

Outcomes

Primary outcome [1]

Comparison of results obtained from dried blood spots samples vs. results obtained from venous blood samples (blood levels of HbA1c, lipids, PSA, hs-CRP, thyroid function tests, creatinine, folate, H-ferritin, L-ferritin, and transferrin).

Timepoint [1]

end 2016

Secondary outcome [1]

Comparison of results obtained from self collected dried blood spots, urine or saliva samples vs. results obtained from mainstream collection methods (levels of hormones/steroids including cortisol, progesterone, testosterone, etc).

Timepoint [1]

end 2017

Eligibility

Key inclusion criteria

Adults > 18 years-old.
Participants fluent in English and able to provide consent for participating in research.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants who do not have restrictions to have their blood drawn (ie. due to religious matters or have donated blood in the 4 weeks prior to the research)
Participants who have no difficulty in providing venous blood samples.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

This study will compare data from samples taken by alternative methods to those of standard pathology methods. Data will be obtained from >100 participants for each test. Linear regression and Bland Altman analysis will be used to compare data. We will use non-parametric tests, ANOVA and Student’s t-test on paired measures

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

Adequate data was collected from study participants to date. No further recruitment is required and data has been analysed

Date of first participant enrolment

Anticipated

12/03/2014

Actual

12/03/2014

Date of last participant enrolment

Anticipated

31/05/2018

Actual

25/07/2018

Date of last data collection

Anticipated

Actual

25/07/2018

Sample size

Target

2000

Accrual to date

Final

741

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

0200 - Australian National University

Recruitment postcode(s) [2]

2747 - Kingswood

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

This research is funded by MyHealthTest Pty Ltd. MyHealthTest Pty Ltd is the body seeking this research and its interests resides only in being provided with the depersonalised results of the research.

Address [1]

MyHealthTest Pty Ltd, Level 7, Building 39, London Crt, Canberra city ACT 2601

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

ACT Government

Address [2]

Business Development and ACT Economic Development Directorate
GPO Box 158
Canberra ACT 2601

Country [2]

Australia

Primary sponsor type

University

Name

The Australian National University

Address

The John Curtin School of Medical Research
Garran Rd, building 131
Acton ACT 0200

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Canberra

Address [1]

Faculty of ESTEM
Building 3, Room D41
University of Canberra
ACT 2601 Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Australian National University Human Research Ethics Committee

Ethics committee address [1]

Research Integrity
Research Services
Chancelry 10B, Lower Ground Floor
East Road
The Australian National University
Acton ACT 0200

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/06/2013

Approval date [1]

10/07/2013

Ethics approval number [1]

2013/329

Summary

Brief summary

This is key research (with the participation of MyHealthTest) to determine if certain human pathology tests using alternative sampling methods can be proven to be as effective as those done with traditional pathology methods.

MyHealthTest is a new online business which will offer human pathology tests and support services direct to the individuals. Customers will order a limited set of targeted tests online and access their test results through a secure online portal. They will also be able to share these results with others including their GP. This will allow individuals to monitor and track aspects of their health and wellness from the convenience of their home. GPs and pharmacists will also be able to order tests for their patients/customers. The types of tests proposed to be offered in the future by MyHealthTest include:

1.	HbA1c the key period test required by diabetics which provides evidence of how well they are managing their health.
2.	Lipid Panel a series of cholesterol tests including Total Cholesterol and Triglycerides.
3.	hs-CRP (high-sensitivity C-reactive protein) - used to determine if you are suffering from a significant infection/inflammation and a good indicator of risk of cardiovascular disease.

One of the test sample collection methods to be used by MyHealthTest is dried blood spots where capillary blood will be placed onto a dried blood spot card via a finger prick. The dried blood spot sample will be done by the customer or their carer. This is different to the mainstream blood collection method, where venipuncture blood collection is the current process usually performed at a pathology collection centre by a phlebotomist or trained nurse. 

Although dried blood spot samples have been used as a new born screening tool for many decades, to date there has been limited use of dried blood spot for diagnostic tests as part of disease management. A number of research projects undertaken by universities and medical schools show comparative results can be obtained between tests done with capillary blood on dried blood spot collection medium and venous blood samples. This evidence has focussed on comparison between the two blood sample types. 

In addition, MyHealthTest want to test the validity of self urine and saliva collection for testing of hormones.

A precondition for MyHealthTest to offer alternative sample collection processes is to ensure the processes will deliver comparative and acceptably precise results to that of the standard samples for various tests. 

The criteria for the proposed dried blood spot, urine and saliva sample collection processes are the sample must:
1.     be able to be collected by a lay-person;
2.     be able to be legally transported through standard post;
3.	not deteriorate during transport
4.	deliver comparative and acceptably precise results 
This research project will compare dried capillary blood, urine and saliva samples against mainstream pathology samples for different pathology tests

Trial website

Trial related presentations / publications

Mastronardi CA, Whittle B, Tunningley R, Neeman T, Paz-Filho G. The use of
dried blood spot sampling for the measurement of HbA1c: a cross-sectional study. 
BMC Clin Pathol. 2015 Jul 8;15:13. doi: 10.1186/s12907-015-0013-5. eCollection
2015. PubMed PMID: 26157353; PubMed Central PMCID: PMC4495815.

Public notes

Contacts

Principal investigator

Name

A/Prof Paul Dugdale

Address

Chronic Disease Management
Level 8, Building 1
Canberra Hospital
Yamba Drive
Garran ACT 2605

Country

Australia

Phone

+61 434669622

Fax

Paul.Dugdale@anu.edu.au

Contact person for public queries

Name

Belinda Whittle

Address

MyHealthTest PO 646, Canberra ACT 2601

Country

Australia

Phone

+61 2 6145 2147

Fax

belinda.whittle@myhealthtest.com

Contact person for scientific queries

Name

Belinda Whittle

Address

MyHealthTest PO 646, Canberra ACT 2601

Country

Australia

Phone

+61 2 6145 2147

Fax

belinda.whittle@myhealthtest.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual participant data is not useful as a research tool. The data is only useful as a collective

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.

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