Condition category
Cancer
Date applied
20/09/2012
Date assigned
21/09/2012
Last edited
26/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Henry Kitchener

ORCID ID

Contact details

Oxford Road
Manchester
M13 9PL
United Kingdom
henry.kitchener@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12823

Study information

Scientific title

Evaluation of cytology and HPV testing for testing for anal intraepithelial neoplasia in high-risk populations in the UK: a non-randomised study

Acronym

ANALOGY

Study hypothesis

Anal cancer, like cervical cancer, involves infection with the human papilloma virus (HPV). Anal cancer is generally uncommon, but there are some people at increased risk. These include people whose immune system is impaired, for example because they have Human immunodeficiency virus (HIV) infection, or have had a transplant and are taking drugs which suppress immunity, and men who have sex with men. It may be worthwhile offering such 'high risk' people testing for anal cancer; this would involve a liquid based cytology (LBC) test for precancerous abnormal cell changes similar to that now used for NHS cervical screening, and possibly a test for high risk HPV. Liquid based cytology, because it filters off impurities, offers the ability to obtain a clear sample of cells from the anus. We do not yet have all the information needed to decide whether testing for anal cancer with the available technologies would be useful. This study is designed to make an initial evaluation of the utility of these tests; to test how easy it would be to recruit the at risk population; to find out what patients feel about screening; and to obtain up to date information for the UK on the numbers of people likely to have an abnormal test result at each stage of the testing process. This initial study involves 1000 people and 4 high risk groups will be tested: HIV positive men who have sex with men; HIV negative men and women who have anal intercourse; kidney transplant patients; and HPV positive women with a history of genital warts/abnormal cytology. Patients will be offered anal cytology and HPV tests, with further tests, including biopsy sampling of anal tissue for diagnosis, for those with abnormal cytology and/or positive HPV tests and, for comparison, for some with normal cytology and negative HPV tests. Those found to have abnormal cells would be offered treatment.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12823

Ethics approval

NRES Committee North West – Greater Manchester North, 14 May 2012, ref:12/NW/0204

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Infection, Generic Health Relevance and Cross Cutting Themes; Subtopic: Infection (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Infectious diseases and microbiology , Surgery

Intervention

Anal cytology: All participants will be offered testing for evidence of abnormality including anal cytology (liquid based cytology), HPV testing, anal HPV testing.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Evaluation of LBC and HPV testing/typing and anoscopy as potential screening tests at end of study

Secondary outcome measures

1. Feasibility of recruitment, screening and follow up
2. Patient acceptability of screening for anal neoplasia
3. Reliable estimates of prevalence of anal cytological abnormality and HPV positivity by type

Measured at end of study

Overall trial start date

01/09/2012

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. HIV positive men and women who have anal intercourse attending NHS genitourinary medicine (GUM) clinics
2. Men who have sex with men (MSM), recruited through GUM clinics and specialist general practices
3. Immunosuppressed transplant recipients (men and women) attending transplant follow-up clinics

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1000; UK Sample Size: 1000

Participant exclusion criteria

Patients with prior history of anal neoplasia

Recruitment start date

01/09/2012

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

Central Manchester University Hospitals NHS Trust (CMFT) (UK)

Sponsor details

St Mary's Hospital
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Health Service Cancer Screening Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes