Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
FLAN
1 other identifier
interventional
20
1 country
1
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 function and patient-reported outcomes before and after laser ablation of HSIL will add to the evidence that such a therapy is an acceptable and safe treatment to offer in a preventative setting.We will be recruting HIV positive and negative MSM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2016
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 31, 2021
August 1, 2021
4.8 years
April 21, 2016
August 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Manometric indices
Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values
Six months
Secondary Outcomes (4)
Anal mucosal sensitivity
6 months
Endoanal ultrasound abnormalities
6 months
Physical and psychological well-being
4 weeks 6 months
Patient reported outcomes
6 months
Study Arms (1)
Anorectal function post anal laser
EXPERIMENTALIntervention: Device: laser
Interventions
functional studies before and after anal laser ablation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Homerton University Hospital NHS Foundation Trust
London, E9 6SR, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tamzin Cuming, FRCS
Homerton University Hospital NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2016
First Posted
September 30, 2019
Study Start
March 1, 2018
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
August 31, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share