Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000645651
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
14/10/2005
Date last updated
14/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
HPV infection and cervial dysplasia in bone marrow transplant recipients
Scientific title
A study to evaluate the impact of immunosuppression associated with bone marrow transplantation on HPV infection and cervial dysplasia, the impact of conditioning regimens on cytology and the difference in outcome parameters between allogeneic and autologous transplant recipients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Marrow Transplant 776 0
Condition category
Condition code
Surgery 851 851 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 488 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1093 0
Evaluate impact of immunosuppression associated with bone marrow transplantation on cervical cytology and HPV infection
Timepoint [1] 1093 0
Over a 5 year period.
Secondary outcome [1] 2029 0
To assess the impact of conditioning regimens on cytology and the difference in outcome parameters between allogeneic and autologous transplant recipients.
Timepoint [1] 2029 0
Over a 5 year period.

Eligibility
Key inclusion criteria
Patients who are about to undergo bone marrow transplantation, either allogeneic or autologous; Patients expected to survive for the 3 year follow up period.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/10/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 938 0
Self funded/Unfunded
Name [1] 938 0
Investigator
Country [1] 938 0
Primary sponsor type
Government body
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 796 0
None
Name [1] 796 0
Nil
Address [1] 796 0
Country [1] 796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2234 0
Royal Melbourne Hospital
Ethics committee address [1] 2234 0
Ethics committee country [1] 2234 0
Australia
Date submitted for ethics approval [1] 2234 0
Approval date [1] 2234 0
Ethics approval number [1] 2234 0
Ethics committee name [2] 2235 0
Alfred Hospital
Ethics committee address [2] 2235 0
Ethics committee country [2] 2235 0
Australia
Date submitted for ethics approval [2] 2235 0
Approval date [2] 2235 0
Ethics approval number [2] 2235 0

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

Contacts
Principal investigator
Name 36342 0
Address 36342 0
Country 36342 0
Phone 36342 0
Fax 36342 0
Email 36342 0
Contact person for public queries
Name 9677 0
Dr Joe Sasadeusz
Address 9677 0
Victorian Infectious Diseases Service
Centre for Clinical Research Excellence in Infectious Diseases
Royal Melbourne Hospital
9 North
9th Floor
Grattan St
Parkville VIC 3050
Country 9677 0
Australia
Phone 9677 0
+61 3 93427212
Fax 9677 0
Email 9677 0
Joe.Sasadeusz@mh.org.au
Contact person for scientific queries
Name 605 0
Dr Joe Sasadeusz
Address 605 0
Victorian Infectious Diseases Service
Centre for Clinical Research Excellence in Infectious Diseases
Royal Melbourne Hospital
9 North
9th Floor
Grattan St
Parkville VIC 3050
Country 605 0
Australia
Phone 605 0
+61 3 93427212
Fax 605 0
Email 605 0
Joe.Sasadeusz@mh.org.au

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.