Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00119509




Registration number
NCT00119509
Ethics application status
Date submitted
11/07/2005
Date registered
13/07/2005
Date last updated
25/04/2007

Titles & IDs
Public title
The IMAP Study Improving Management of Mildly Abnormal Pap Smears
Scientific title
HPV DNA Testing Versus Conventional Management for Women With Minor Atypia on Pap Smear: Psychosocial and Quality of Life Outcomes and Development of a Decision Analytic Model
Secondary ID [1] 0 0
211205_IMAP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervix Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Psychosocial wellbeing assessed using psychometric scales including (a) global measures of psychological health (STAI, SF36)and (b) measures specific to cervical screening.
Timepoint [1] 0 0
Primary outcome [2] 0 0
Quality of Life (Utility) Assessment two stage standard gamble (SG) technique produces a utility score between 0 and 1.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Clinical outcomes: results of follow-up Pap smear and Colposcopy and HPV testing
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Management preference: women's preference for HPV or repeat Pap testing measured by a Decision Aid.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Decision Aid evaluation: Measure the impact of the DA of knowledge, decisional conflict, and satisfaction with decision making
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* Women with ONLY the following results on a routine Pap smear:

* Low grade epithelial abnormality;
* Minor changes in squamous cell;
* Minor changes in squamous cells with appearances consistent with Papillomavirus
* Women aged between 18-70 years
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or planning to become pregnant in the next 12 months
* Women with previous Pap smear abnormality for 2 years.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2008
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
North Coast Community Health Centre - Port Macquarie
Recruitment hospital [2] 0 0
Family Planning Association - Sydney
Recruitment hospital [3] 0 0
Taree Community Health Centre - Taree
Recruitment hospital [4] 0 0
Illawarra Women's Health Centre - Warilla
Recruitment hospital [5] 0 0
Family Planning Queensland - Brisbane
Recruitment hospital [6] 0 0
Shine SA - Adelaide
Recruitment hospital [7] 0 0
Family Planning Western Australia - Perth
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2430 - Taree
Recruitment postcode(s) [4] 0 0
2528 - Warilla
Recruitment postcode(s) [5] 0 0
4006 - Brisbane
Recruitment postcode(s) [6] 0 0
5068 - Adelaide
Recruitment postcode(s) [7] 0 0
6865 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Family Planning Association New South Wales
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kirsten McCaffery, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00119509