Status:
UNKNOWN
Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
Lead Sponsor:
Homerton University Hospital NHS Foundation Trust
Collaborating Sponsors:
Barts & The London NHS Trust
Conditions:
Anus Cancer
Fecal Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
High-grade squamous intraepithelial lesions (HSIL) and anal cancer are rising in incidence and at highest risk are HIV positive men who have sex with men (MSM). This pilot study assessing anal functio...
Detailed Description
High resolution anoscopy with targeted laser ablation is one of the therapies currently employed to treat HSIL of the anus to prevent progression to anal cancer. The functional outcome of this procedu...
Eligibility Criteria
Inclusion
- MSM \>18 years of age if HIV positive, CD4 count of over 350; if less, been on highly active antiretroviral treatment for at least 3 months Histologically proven high-grade squamous anal intraepithelial neoplasia lesion (HSIL) Anal canal disease with or without perianal disease Written informed consent
Exclusion
- Previous laser or other ablative treatment for HSIL (previous topical treatment is not excluded) Any treatment for HSIL in the previous six months Previous or current diagnosis of anal cancer Concurrent or previous (if severe) perianal inflammatory bowel disease, complex fistula or other significant perianal condition requiring surgery including fissures, current fistula in ano and Grade III or IV haemorrhoids Perianal sepsis Perianal disease only without anal canal HSIL
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04109573
Start Date
March 1 2018
End Date
December 1 2022
Last Update
August 31 2021
Active Locations (1)
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1
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR