Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001335785
Ethics application status
Approved
Date submitted
28/11/2013
Date registered
6/12/2013
Date last updated
7/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Study of the Prevention of Anal Cancer in Homosexual Men
Scientific title
The Natural History of Anal Human Papillomavirus (HPV) Infection and Anal Cellular Abnormalities in Homosexual Men
Secondary ID [1] 283660 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
SPANC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal Cancer 290611 0
Incidence of HPV in Homosexual Men 290612 0
Condition category
Condition code
Public Health 291002 291002 0 0
Epidemiology
Cancer 291016 291016 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High Resolution Anoscopy (HRA) is being used to determine if the study will provide important information to guide the possible future introduction of anal cancer screening program for gay men. The HRA examination takes about 20 minutes for perform. It is not generally painful, due to local anaesthesia given prior to the procedure. Mild, transient anal bleeding may occur, for 72 hours after the procedure. The HRA procedure is conducted at Baseline and all 4 follow up visits which occur 6 months after Baseline and then annually to 36 months. There is a very small risk of a significant post-procedure haemorrhage. During the seven days after the procedure, it is possible that this may increase the risk of HIV infection should the participant have unprotected receptive anal intercourse. The procedure itself, and awaiting the pathology result, may cause anxiety in some participants. After having this procedure the participants are advised not to have receptive anal intercourse for at least 7 days. As a result of this procedure some participants may be referred for treatment of anal abnormalities.
Intervention code [1] 288362 0
Early detection / Screening
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290984 0
To determine if the study will provide important information to guide the possible future introduction of anal cancer screening programs for gay men. This is assessed by the conduct of the high resolution anoscopy and the HPV test.
Timepoint [1] 290984 0
2018
Secondary outcome [1] 305746 0
Among homosexual men aged 35 or above to determine the prevalence, incidence and risk factors for specific types of HPV infection; At Baseline visit, all men will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. A high resolution anoscopy (HRA) will also be performed on all men. Biopsy samples will be taken by the study doctor for histological assessment if there are any detected abnormalities. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th visit to discuss all study results will take place 2-3 months after the 5th study visit. a behavioural questionnaire, an anal swab, a HRA will be administered at all follow up interview visits. Blood will be collected at all visits except at visit 2 (six-month visit).
Timepoint [1] 305746 0
2018
Secondary outcome [2] 305800 0
Prevalence, incidence and risk factors for histologically confirmed and low grade and high grade squamous intraepithelial lesions (HSIL and LSIL);
Timepoint [2] 305800 0
2018
Secondary outcome [3] 305801 0
Type specific rates of clearance and persistence of anal HPV infection;
Among homosexual men aged 35 or above to determine the prevalence, incidence and risk factors for specific types of HPV infection; At Baseline visit, all men will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. A high resolution anoscopy (HRA) will also be performed on all men. Biopsy samples will be taken by the study doctor for histological assessment if there are any detected abnormalities. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th visit to discuss all study results will take place 2-3 months after the 5th study visit. a behavioural questionnaire, an anal swab, a HRA will be administered at all follow up interview visits. Blood will be collected at all visits except at visit 2 (six-month visit).
Timepoint [3] 305801 0
2018
Secondary outcome [4] 305802 0
Rates of disease progression, regression and predictors in the spectrum of anal dysplasia;
Among homosexual men aged 35 or above to determine the prevalence, incidence and risk factors for specific types of HPV infection; At Baseline visit, all men will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. A high resolution anoscopy (HRA) will also be performed on all men. Biopsy samples will be taken by the study doctor for histological assessment if there are any detected abnormalities. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th visit to discuss all study results will take place 2-3 months after the 5th study visit. a behavioural questionnaire, an anal swab, a HRA will be administered at all follow up interview visits. Blood will be collected at all visits except at visit 2 (six-month visit).
Timepoint [4] 305802 0
2018
Secondary outcome [5] 305803 0
Psychosocial and quality of life impact of anal cytology screening in homosexual men.

Participants will be asked a series of questions via computer-assisted self-interviewing about their history and recent experiences of anal intercourse in the last six months, including protected and unprotected; other anal sexual practices. Questions considered also include oral sexual practices and demographics, and possible anal cancer risk factors such as cigarette smoking.
Timepoint [5] 305803 0
The results of the participants visit are received and reviewed within 2 weeks of collection.

Two weeks after participants receive their anal screening test results, participants are asked by the research assistant to complete a two week post anal screening psychological assessment questionnaire online or by post (if preferred). This includes the SF36 version 2 questionnaire, distress thermometer, cancer worry and intrusive thoughts questions. A reminder will be sent two weeks later to non-responders and telephone follow-up if no response is received after four weeks.
Participants who score 6 or 7 or the distress thermometer will be prompted to call the study nurse for support. Participants who score 8 or above will be notified that a study nurse will contact them. The study nurse will further assess the psychological health and wellbeing of these participants. Referral to special psychological services will be offered if indicated.

Eligibility
Key inclusion criteria
The inclusion criteria are: male homosexual aged 35 years or above; HIV positive participants: documented to be HIV positive; HIV negative participants: tested HIV negative at recruitment; provision of informed, written consent.
Minimum age
35 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are: participants unable to attend scheduled follow-up interviews or unwilling to undergo high resolution anoscopies (HRA); unable to understand English; having bleeding disorders or currently taking anti-coagulant medications; having previously received HRA; having ever been diagnosed with anal cancer.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from community based settings in Sydney which are frequented by homosexual men 35 years or older.
Study leaflets will be distributed at these community based organisations and presentations about the study will be given by the researchers at social gatherings. Potentials participants who are 35 years or older and have not been diagnosed with anal cancer are invited to contact the study for further assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be recruited from community based settings in Sydney which are frequented by homosexual men 35 years or older.
Study leaflets will be distributed at these community based organisations and presentations about the study will be given by the researchers at social gatherings. Potentials participants who are 35 years or older and have not been diagnosed with anal cancer are invited to contact the study for further assessment.
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
Assuming the incidence of HSIL is 5 and 15 per 100 person-years in HIV negative and HIVB positive men, respectively, the 95% confidence intervals will be 4.2 - 6.0 in the HIV negative arm and 12.6 - 17.8 per 100 person-years in the HIV positive arm. Analysis plan: HPV prevalence and incidence, including overall, low risk, high risk and individual types, will be calculated according to participants HIV status. Prevalence and incidence of LSIL and HSIL will be calculated in the same fashion. Clearance and persistence of HPV infection, and progression and regression of HSIL will also be determined. Risk factors for prevalent HPV infection and LSIL and HSIL will be analysed using logistical regression. Risk factors for incident conditions will be analysed using Cox regression.

Please note that the SPANC study is a prospective cohort study of the national history of anal human papillomavirus (HPV) infection and anal cellular abnormalities in homosexual men aged 35 years and above in Sydney. It is expected that the study results will be influential in the possible development of an anal cancer screening program in high-risk populations. Data on the natural history of anal HPV infection in homosexual men recruited from community-based settings are rare. We aim to recruit a total of 600 men, 360 HIV-negative and 240 HIV-positive. This will make the SPANC study one of the biggest ongoing anal HPV natural history study in the world to provide critical data on the incidence and clearance of anal HPV infection, progression and regression of pre-cancerous HPV associated anal lesions, the potential psychological impact on men who participate anal cancer screening programs, and the cost-effectiveness of rolling out these programs.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/09/2010
Date of last participant enrolment
Anticipated
31/07/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7586 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 7587 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 288346 0
Government body
Name [1] 288346 0
Cancer Council of New South Wales
Country [1] 288346 0
Australia
Funding source category [2] 288347 0
Government body
Name [2] 288347 0
National Health and Medical Research Council
Country [2] 288347 0
Australia
Primary sponsor type
University
Name
University of New South Wales, Sydney Australia
Address
Anzac Parade
Kensington
New South Wales, 2032
Country
Australia
Secondary sponsor category [1] 287056 0
University
Name [1] 287056 0
The Kirby Institute, UNSW, Medicine
Address [1] 287056 0
Corner of West and Boundary Streets
Darlinghurst
New South Wales, 2010
Country [1] 287056 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This is a study of anal (HPV) infection and related anal disease in gay men. Both HIV positive and HIV negative men are eligible. You should not have been previously diagnosed with anal cancer.

All participants in this study will undergo high resolution anoscopy during the study over 36 months. The first HRA will be conducted at Baseline and at all 4 follow up visits. The high resolution anoscopy involves, examination of the peri-anal region and perineum, and the a plastic anoscope is inserted into the anal canal. Following staining of the anal canal with acetic acid and lugol's solution, the anal canal is visualised under high resolution magnification. Biopsy samples will be taken by the clinician for histological assessment if there are any detected abnormalities. The data collected from these examinations will be used to determine the prevalence, incidence and risk factors for specific types of human papillomavirus (HPV) infection. There are more than 100 type of HPV. Some cause genital warts and other types cause more than 90% of anal cancer. Gay men are over 20 times more likely than others to develop anal cancer. The information collected in this study may guide the possible future introduction of anal cancer screening programs for gay men.
Trial website
http://www.kirby.unsw.edu.au
http://www/nchecrsurveys.unsw.edu.au/spanc/
Trial related presentations / publications
Machalek DA, Grulich AE, Hillman RJ, Jin F, Templeton DJ, Tabrizi SN, Garland SM, Prestage G, McCaffery K, Howard K, Tong W, Fairley CK, Roberts J, Farnsworth A, Poynten IM; SPANC study team. The Study of the Prevention of Anal Cancer (SPANC: design and methods of a three- year - prospective cohort study. BMC Public Health. 2013 Oct 9; 13:946. doi: 10.1186/1471-2458-13-946
Public notes

Contacts
Principal investigator
Name 44590 0
Prof Andrew Grulich
Address 44590 0
Kirby Institute
CFI Building
Corner West and Boundary Streets
Darlinghurst, NSW 2010
Country 44590 0
Australia
Phone 44590 0
+612 93850956
Fax 44590 0
Email 44590 0
agrulich@kirby.unsw.edu.au
Contact person for public queries
Name 44591 0
Dr Mary Poynten
Address 44591 0
Kirby Institute
CFI Building
Corner West and Boundary Streets
Darlinghurst, NSW 2010
Country 44591 0
Australia
Phone 44591 0
+612 93850937
Fax 44591 0
Email 44591 0
mpoynten@kirby.unsw.edu.au
Contact person for scientific queries
Name 44592 0
Dr Richard Hillman
Address 44592 0
Western Sydney Sexual Health Centre
Jeffery House
162 Marsden Street
Parramatta NSW 2150
Country 44592 0
Australia
Phone 44592 0
+612 97625378
Fax 44592 0
Email 44592 0
Richard.Hillman@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23303Study protocolThe Study of the Prevention of Anal Cancer (SPANC): design and methods of a three-year prospective cohort study. Machalek DA, Grulich AE, Hillman RJ, Jin F, Templeton DJ, Tabrizi SN, Garland SM, Prestage G, McCaffery K, Howard K, Tong W, Fairley CK, Roberts J, Farnsworth A, Poynten IM; SPANC Study Team. BMC Public Health. 2013   

Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4446Study results articleYes Machalek DA et al The Study of the Prevention of A... [More Details]

Documents added automatically
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