Condition category
Cancer
Date applied
20/09/2012
Date assigned
21/09/2012
Last edited
05/01/2017
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
+44 161 306 6000
henry.c.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

The aim of this study is to make an initial evaluation of the utility of offering 'high risk' people testing for anal cancer; 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.

Ethics approval

NRES Committee North West – Greater Manchester North, 14/05/2012, ref: 12/NW/0204

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

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

05/01/2017: No publications found in PubMed, verifying study status with principal investigator.