Study of the Prevention of Anal Cancer (SPANC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Kirby Institute
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT02007421
First received: November 26, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Human Papillomavirus
Cancer
Procedure: Participants asked questions about recent experiences of anal intercourse in the last six months.
Procedure: High Resolution Anoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Natural History of Anal Human Papillomavirus Infection and Anal Cellular Abnormalities in Homosexual Men

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • A natural history study to inform the potential usefulness of a cytology/HPV/HRA based screening program [ Time Frame: 3 year cohort study ] [ Designated as safety issue: No ]
    Aims to determine the prevalence, incidence and risk factors for type-specific HPV (37 types)


Secondary Outcome Measures:
  • Prevalence, incidence and risk factors for LSIL and HSIL [ Time Frame: 3 year cohort study ] [ Designated as safety issue: No ]
    To determine if HPV is associated with LSIL and HSIL


Estimated Enrollment: 600
Study Start Date: September 2010
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Procedure: 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.

Other Name: Participants have venepuncture, anal swab and examination under microscope .
Procedure: 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.
Other Name: HRA
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.

Procedure: 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.

Other Name: Participants have venepuncture, anal swab and examination under microscope .
Procedure: 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.
Other Name: HRA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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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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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007421

Contacts
Contact: Mary Poynten, MBBS,DCH,MPH,PhD +612 93850937 mpoynten@kirby.unsw.edu.au
Contact: Andrew Grulich, MBBS,PhD, FAPHM +612 93850956 agrulich@kirby.unsw.edu.au

Locations
Australia, New South Wales
Applied Medical Research (AMR CRP), St. Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Carmella Law, MBBS    +612 8382 3106    claw2@stvincents.com.au   
Contact: Daniel Seeds, BA nursing (Honours)    +612 8382 3106    dseeds@stvincents.com.au   
Principal Investigator: Carmella Law, MBBS         
RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown Recruiting
Sydney, New South Wales, Australia, 2050
Contact: David Templeton, MBChB    +612 9515 1200    david.templeton@email.cs.nsw.gov.au   
Contact: Brett Sinclair, BA Nursing    +612 9515 1200    Brett.sinclair@sswahs.nsw.gov.au   
Principal Investigator: David Templeton, MBChB         
Sponsors and Collaborators
Kirby Institute
Investigators
Principal Investigator: Carmella Law, MBBS; FAChSHM; Appplied Medical Research, the Clinical Research Program at St. Vincent's Hospital
Principal Investigator: David Templeton, MBChB; PhD; RPA Sexual Health, Royal Prince Alfred Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02007421     History of Changes
Other Study ID Numbers: SPANC, NHMRC
Study First Received: November 26, 2013
Last Updated: December 18, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Kirby Institute:
Human Papillomavirus,
Anal High Grade Squamous intraepithelial lesions,
Homosexual Men
High resolution anoscopy,
Cancer Screening
HIV

ClinicalTrials.gov processed this record on September 22, 2014