Evaluation of cytology and HPV testing for testing for anal intraepithelial neoplasia in high-risk populations in the UK
| ISRCTN | ISRCTN69055668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69055668 |
| Protocol serial number | 12823 |
| Sponsor | Central Manchester University Hospitals NHS Trust (CMFT) (UK) |
| Funder | National Health Service Cancer Screening Programme (UK) |
- Submission date
- 20/09/2012
- Registration date
- 21/09/2012
- Last edited
- 05/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Prof Henry Kitchener
Scientific
Scientific
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 161 306 6000 |
|---|---|
| henry.c.kitchener@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 |
| Study acronym | ANALOGY |
| Study objectives | 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(s) | NRES Committee North West Greater Manchester North, 14/05/2012, ref: 12/NW/0204 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Evaluation of LBC and HPV testing/typing and anoscopy as potential screening tests at end of study |
| Key secondary outcome measure(s) |
1. Feasibility of recruitment, screening and follow up |
| Completion date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1000 |
| Key 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 |
| Key exclusion criteria | Patients with prior history of anal neoplasia |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oxford Road
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/01/2017: No publications found in PubMed, verifying study status with principal investigator.
