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 |
| Secondary identifying numbers | 12823 |
- 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
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
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | NRES Committee North West Greater Manchester North, 14/05/2012, ref: 12/NW/0204 |
| 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 |
| Primary outcome measure | 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 study start date | 01/09/2012 |
| Overall study end date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1000; UK Sample Size: 1000 |
| 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 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
- England
- United Kingdom
Study participating centre
Oxford Road
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
Central Manchester University Hospitals NHS Trust (CMFT) (UK)
Hospital/treatment centre
Hospital/treatment centre
St Mary's Hospital
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Government
National Health Service Cancer Screening Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
05/01/2017: No publications found in PubMed, verifying study status with principal investigator.
