NCT02007421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
617

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

7.7 years

First QC Date

November 26, 2013

Last Update Submit

November 28, 2019

Conditions

Human PapillomavirusCancer

Keywords

Human Papillomavirus,Anal High Grade Squamous intraepithelial lesions,Homosexual MenHigh resolution anoscopy,Cancer ScreeningHIV

Outcome Measures

Primary Outcomes (1)

  • A natural history study to inform the potential usefulness of a cytology/HPV/HRA based screening program

    Aims to determine the prevalence, incidence and risk factors for type-specific HPV (37 types)

    3 year cohort study

Secondary Outcomes (1)

  • Prevalence, incidence and risk factors for LSIL and HSIL

    3 year cohort study

Study Arms (2)

HIV positive homosexual men

OTHER

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.Procedure: High Resolution Anoscopy

HIV negative homosexual men

OTHER

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.Procedure: High Resolution Anoscopy

Interventions

Participants asked questions about recent experiences of anal intercourse in the last six months.PROCEDURE

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.

Also known as: Participants have venepuncture, anal swab and examination under microscope .
HIV negative homosexual menHIV positive homosexual men
High Resolution AnoscopyPROCEDURE

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.

Also known as: HRA
HIV negative homosexual menHIV positive homosexual men

Eligibility Criteria

Age35 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Applied Medical Research (AMR CRP), St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown

Sydney, New South Wales, 2050, Australia

Location

Related Publications (2)

  • 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.

    PMID: 24107134BACKGROUND

  • Tong WW, Shepherd K, Garland S, Meagher A, Templeton DJ, Fairley CK, Jin F, Poynten IM, Zaunders J, Hillman RJ, Grulich AE, Kelleher AD, Carr A; Study of the Prevention of Anal Cancer (SPANC) team. Human papillomavirus 16-specific T-cell responses and spontaneous regression of anal high-grade squamous intraepithelial lesions. J Infect Dis. 2015 Feb 1;211(3):405-15. doi: 10.1093/infdis/jiu461. Epub 2014 Aug 19.

    PMID: 25139018DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 10, 2013

Study Start

September 10, 2010

Primary Completion

May 4, 2018

Study Completion

December 4, 2018

Last Updated

December 2, 2019

Record last verified: 2019-11

Locations

AU(2)