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Trial registered on ANZCTR


Registration number
ACTRN12616001507471
Ethics application status
Approved
Date submitted
27/10/2016
Date registered
1/11/2016
Date last updated
25/11/2019
Date data sharing statement initially provided
6/12/2018
Date results information initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Screening for Human Papilloma virus (HPV) Infection in Kidney Transplant Recipients for Anal Neoplasia (TAN) - A Prevalence and Feasibility Study
Scientific title
Prevalence and Feasibility of Evaluating Human Papillomavirus Infection & Anal Cellular Abnormalities in Renal Transplant Recipients
Secondary ID [1] 290393 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TAN (Transplant Anal Neoplasia)
Linked study record
ACTRN12613001335785 - The Study of the Prevention of Anal Cancer in Homosexual Men (SPANC)

Health condition
Health condition(s) or problem(s) studied:
HPV infection 300720 0
Anal neoplasia 300723 0
Chronic kidney disease 300724 0
Renal transplant 300725 0
Sexual health 300726 0
Condition category
Condition code
Infection 300561 300561 0 0
Sexually transmitted infections
Renal and Urogenital 300562 300562 0 0
Kidney disease
Cancer 300563 300563 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: anal swab

Kidney transplant recipients attending routine review appointments will be approached to participate. They will be provided a participant information and consent form (PICF) detailing the purpose, methods and risks and benefits of the study. The study will include adults willing and able to give informed consent in English. Consented participants will complete an initial coded demographic and behavioural questionnaire. Trained staff will then take an anal swab taken using a moistened Dacron swab for subsequent HPV testing. The Dacron swab will be vigorously eluded into a ThinPrep (Hologic) vial containing PreservCyt fixative medium. Any participant with either a significant cytological abnormality, or in whom high risk HPV is detected, will be referred for further investigation at a specialist clinic. A letter will be sent to participants with negative or low-risk results as well as their nominated GP.

This pilot study will evaluate the feasibility of collecting potentially sensitive behavioural data, taking anal swab specimens and performing rectal examinations, in order to identify those at high risk of serious disease.
Intervention code [1] 296225 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299979 0
Prevalence of type-specific anal human papilloma virus (HPV) infection in renal transplant recipients, using PCR amplification of target DNA, and hybridization with a reverse line blot system.
Timepoint [1] 299979 0
Anal swab will be performed within 14 days after completion of baseline questionnaire. Genotyping will be performed in batches, for every 20 participant samples.
Primary outcome [2] 299980 0
Prevalence and type of anal cytological abnormalities in renal transplant recipients, using ThinPrep (Hologic) standard procedure.
Timepoint [2] 299980 0
Anal swab will be performed within 14 days after completion of baseline questionnaire. Cytology testing will be performed within 7 days of sample collection.
Primary outcome [3] 299994 0
Feasibility of use of anal swabs as a screening tool for the detection of HPV infection and abnormal cytological abnormalities. This will be assessed through enrolment rates from all eligible approached participants and also feedback given in the baseline questionnaires.
Timepoint [3] 299994 0
Feasibility will be assessed after all participants have been tested, and followed up if needed.
Secondary outcome [1] 328740 0
Any correlations between virological or cytological results, via anal swab analysis and demographic or behavioural characteristics highlighted from the baseline questionnaire. The TAN Baseline Interview Questionnaire on Demographics and Behaviour was adapted from an Audio Computer-Assisted Self-Interview designed for the SPANC study, investigating HPV infection, anal neoplasia and behavioural characteristics in homosexual men.
Timepoint [1] 328740 0
After completion of behavioural questionnaire and intervention.

Eligibility
Key inclusion criteria
1. Able to give written, informed consent in English
2. Female and male adults, aged 18 years or over
3. Attending the site for either assessment for a kidney transplant, on the kidney transplant waiting list, or for follow-up care as a kidney transplant recipient
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide informed consent
2. Previous anal cancer
3. Other anal pathology likely to be associated with significant anal bleeding when the anal swab is taken

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a pilot convenience sample cohort study of 100 participants.
The HPV prevalence of all the participants, to include the prevalence for any HPV infection and also separate analysis of low-risk, high-risk and individually, once the study is completed further sub analysis for transplant status, length of time on immunosuppression and behavioural factors. Prevalence of cytologically confirmed LSIL and HSIL will be calculated in the same fashion. Risk factors for prevalent HPV infection and HSIL will be analysed using logistic regression.


Recruitment
Recruitment status
Completed
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)
NSW
Recruitment hospital [1] 9217 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 17873 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 294799 0
University
Name [1] 294799 0
Sydney Medical School Foundation Research Grant, The University of Sydney
Address [1] 294799 0
Sydney Medical School Foundation
Room 204
Edward Ford Building A27
The University of Sydney NSW 2006
Country [1] 294799 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Centre for Transplant and Renal Research, A6c Westmead Hospital, Cnr Hawkesbury and Darcy Roads, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 293638 0
None
Name [1] 293638 0
Address [1] 293638 0
Country [1] 293638 0
Other collaborator category [1] 279278 0
University
Name [1] 279278 0
University of Sydney
Address [1] 279278 0
School of Public Health
Edward Ford Building (A27)
The University of Sydney
NSW 2006 Australia
Country [1] 279278 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296197 0
WSLHD Human Research Ethics Committee
Ethics committee address [1] 296197 0
Research Office, Level 2, REN Building
Westmead Hospital, Hawkesbury & Darcy Roads,
Westmead NSW 2145
Ethics committee country [1] 296197 0
Australia
Date submitted for ethics approval [1] 296197 0
13/11/2014
Approval date [1] 296197 0
21/01/2015
Ethics approval number [1] 296197 0
(4136) AU RED HREC/14/WMEAD/421

Summary
Brief summary
The primary purpose of this trial is to evaluate the feasibility of providing screening for human papilloma virus (HPV) infection of the anus in patients who have had or who are on the waiting list for a kidney transplant at Westmead Hospital. The trial also aims to provide initial estimates of the prevalence of HPV infection in this population.

Who is it for?
You may be eligible to enroll in this trial if you are aged over 18 years, and you have had or are on the waiting list for a kidney transplant at Westmead Hospital.

Study details
At a routine assessment visit, all participants will complete a questionnaire for demographic and sexual behaviour information, and have an anal swab taken. The sample will be analysed for different types of HPV infection and to see if any abnormal cells are present. Any participant with either a significant cytological abnormality, or in whom high risk HPV is detected, will be referred for further investigation at a specialist clinic.

It is hoped that this trial will provide information on whether it is feasible to collect this information in transplant recipients, as well as providing initial estimates of the prevalence of HPV.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69946 0
A/Prof Richard Hillman
Address 69946 0
Western Sydney Sexual Health, Level 4, Jeffery House
162 Marsden Street, Parramatta NSW 2150
Country 69946 0
Australia
Phone 69946 0
+61 2 9762 5378
Fax 69946 0
Email 69946 0
richard.hillman@sydney.edu.au
Contact person for public queries
Name 69947 0
Miss Brenda Rosales
Address 69947 0
Level 2, Charles Perkins Centre (D17), The University of Sydney, NSW, 2006


Country 69947 0
Australia
Phone 69947 0
+61 422 760 787
Fax 69947 0
Email 69947 0
brenda.rosales@sydney.edu.au
Contact person for scientific queries
Name 69948 0
A/Prof Angela Webster
Address 69948 0
Centre for transplant and renal research, A6c Westmead Hospital, Cnr Hawkesbury and Darcy Roads, Westmead NSW 2145
Country 69948 0
Australia
Phone 69948 0
+61 2 9036 9125
Fax 69948 0
Email 69948 0
angela.webster@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics does not permit identification of individuals recruited to the study. In order to assess whether individual participant data can be shared, we would need to ensure patients cannot be identified from current information collected in surveys.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary