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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02007421
Registration number
NCT02007421
Ethics application status
Date submitted
26/11/2013
Date registered
10/12/2013
Date last updated
2/12/2019
Titles & IDs
Public title
Study of the Prevention of Anal Cancer
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Scientific title
The Natural History of Anal Human Papillomavirus Infection and Anal Cellular Abnormalities in Homosexual Men
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Secondary ID [1]
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NHMRC
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Secondary ID [2]
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SPANC
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Universal Trial Number (UTN)
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Trial acronym
SPANC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus
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Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Participants asked questions about recent experiences of anal intercourse in the last six months.
Treatment: Surgery - High Resolution Anoscopy
Other: HIV positive homosexual men - Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.
At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews.
Other: HIV negative homosexual men - Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.
At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews.
Treatment: Surgery: Participants asked questions about recent experiences of anal intercourse in the last six months.
Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.
At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews.
Treatment: Surgery: High Resolution Anoscopy
The HRA is performed on HIV positive and HIV negative participants by study doctor after an examination of the perianal region and perineum. The plastic anoscope is inserted into the anal canal and visualised under high resolution magnification. Biopsy samples will be taken by the clinician for histological assessment if there are any detected abnormalities.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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A natural history study to inform the potential usefulness of a cytology/HPV/HRA based screening program
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Assessment method [1]
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Aims to determine the prevalence, incidence and risk factors for type-specific HPV (37 types)
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Timepoint [1]
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3 year cohort study
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Secondary outcome [1]
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Prevalence, incidence and risk factors for LSIL and HSIL
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Assessment method [1]
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To determine if HPV is associated with LSIL and HSIL
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Timepoint [1]
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3 year cohort study
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Eligibility
Key inclusion criteria
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.
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Minimum age
35
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/09/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/12/2018
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Sample size
Target
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Accrual to date
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Final
617
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Applied Medical Research (AMR CRP), St. Vincent's Hospital - Sydney
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Recruitment hospital [2]
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RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown - Sydney
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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2050 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Kirby Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of
human papillomavirus (HPV). Some HPV types 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.
SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will
provide important information to guide the possible future introduction of anal cancer
screening programs for gay men.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02007421
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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.
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Public notes
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Contacts
Principal investigator
Name
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Carmella Law, MBBS; FAChSHM;
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Address
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Appplied Medical Research, the Clinical Research Program at St. Vincent's Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02007421
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