Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000909224
Ethics application status
Approved
Date submitted
19/10/2009
Date registered
21/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The AC Rule for Melanoma
Scientific title
The AC Rule for Melanoma: a simple educational intervention for the wider community which will achieve high sensitivity for melanoma detection.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 252027 0
Condition category
Condition code
Cancer 252220 252220 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants view an educational brochure on the AC Rule for melanoma detection. They then view a series of pigmented skin lesions, and try to identify those that are suspicious of melanoma. Participants can refer to the brochure throughout the trial. There are two image sets of 100 lesions, viewed between 1 day and two weeks apart. Each image set takes approximately 1 hour to complete. Responses are recorded on paper, on a seperate results sheet for each lesion.
Intervention code [1] 241427 0
Early detection / Screening
Comparator / control treatment
The same experiment is also undertaken by medical students and expert dermatologists as two comparative groups. All groups will receive the educational brochure. There is no control group in this experiment. Overall assessments for suspicion of melanoma will be compared with histopathology results for each lesion, which is the gold standard for melanoma diagnosis. This is how values for sensitivity and specificity for melanoma diagnosis will be calculated for each study group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253090 0
Sensitivity for clinical melanoma identification. Sensitivity is the percentage of histopathologically proven melanomas that are assessed as "suspicious" for melanoma by the participants
Timepoint [1] 253090 0
Immediately following participants answers
Primary outcome [2] 253094 0
Specificity for clinical melanoma identification. Specificity is the percentage of histopathologically proven benign naevi that are assessed as "not suspicious" for melanoma by the participants
Timepoint [2] 253094 0
Immediately following participants answers
Primary outcome [3] 253095 0
Positive likelihood ratios for clinical melanoma identification. Calculated from sensitivity and specificity values obtained above.
Positive Likelihood Ratio = sensitivity/1-specificity
Timepoint [3] 253095 0
Immediately following participants answers
Primary outcome [4] 253096 0
Negative likelihood ratios for clinical melanoma identification.Calculated from sensitivity and specificity values obtained above.
Negative Likelihood Ratio
= 1-sensitivity/specificity
Timepoint [4] 253096 0
Immediately following participants answers
Secondary outcome [1] 257956 0
Nil
Timepoint [1] 257956 0
Nil

Eligibility
Key inclusion criteria
None
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Professional health care training or experience

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243898 0
Self funded/Unfunded
Name [1] 243898 0
Nil
Country [1] 243898 0
Australia
Primary sponsor type
Individual
Name
Matthew Luttrell
Address
3/12 Fleming Rd
Herston QLD, 4006
Country
Australia
Secondary sponsor category [1] 251246 0
None
Name [1] 251246 0
Address [1] 251246 0
Country [1] 251246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244014 0
Medical research Ethics Committee
Ethics committee address [1] 244014 0
Ethics committee country [1] 244014 0
Australia
Date submitted for ethics approval [1] 244014 0
Approval date [1] 244014 0
23/09/2009
Ethics approval number [1] 244014 0
2009001413

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

Contacts
Principal investigator
Name 30399 0
Address 30399 0
Country 30399 0
Phone 30399 0
Fax 30399 0
Email 30399 0
Contact person for public queries
Name 13646 0
Matthew Luttrell
Address 13646 0
3/12 Fleming Rd, Herston QLD Australia 4006
Country 13646 0
Australia
Phone 13646 0
+61 405440566
Fax 13646 0
Email 13646 0
[email protected]
Contact person for scientific queries
Name 4574 0
Matthew Luttrell
Address 4574 0
3/12 Fleming Rd, Herston QLD Australia 4006
Country 4574 0
Australia
Phone 4574 0
+61 405440566
Fax 4574 0
Email 4574 0
[email protected]

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.