Transplant recipients and Anal Neoplasia (TAN) study dataset
The University of SydneyDataset description
This dataset includes up to 125 kidney transplant recipients recruited from Westmead Hospital, New South Wales, Australia. Baseline data includes demographics, risk factors of HPV-associated anal squamous cell cancer, cigarette smoking, sexual behaviours, history of anogenital warts and previous abnormal cervical cytology, concurrent but unrelated anal conditions and sexual practices. Clinical data such as date of transplantation, time on waiting list and current immunosuppression treatment were obtained from patients' clinical records. Anal swab test results for HPV detection and genotyping and cytopathology were collected.Identifiers
Source Study
Purpose:
Phase:
Trial acronym
TAN (Transplant Anal Neoplasia)
Trial ID
ACTRN12616001507471
Funding
University, Sydney Medical School Foundation Research Grant, The University of Sydney
Scientific enquiries
A/Prof Angela Webster
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 trans .... Read more
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
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
Can healthy volunteers participate?
No
Population
Sample Size 97
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Anal neoplasia , Chronic kidney disease , HPV infection , Renal transplant , Sexual health
Condition code Cancer , Infection , Renal and Urogenital
Intervention
Intervention code Early detection / Screening
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 .... Read more
Comparison
Control group Uncontrolled
No control group
Outcomes
Outcome: 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: Feasibility will be assessed after all participants have been tested, and followed up if needed.
Outcome: 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: Anal swab will be performed within 14 days after completion of baseline questionnaire. Genotyping will be performed in batches, for every 20 participant samples.
Outcome: Prevalence and type of anal cytological abnormalities in renal transplant recipients, using ThinPrep (Hologic) standard procedure. Timepoint: Anal swab will be performed within 14 days after completion of baseline questionnaire. Cytology testing will be performed within 7 days of sample collection.
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All participant data collected
When will data be available?
Data are available straight after publication Data are available for an indefinite time Start date: July 2023 End date: Unknown
Available to whom?
Data are potentially available to: - Researchers from not-for-profit organisations - Commercial organisations - Other Based in: Any location Further information: All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal and are subject to ethics and governance approvals.
Available for what types of analyses?
IPD meta-analysis or systematic review. Assessed on a case-by-case basis.