- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04109573
Function Following Laser for Anal Intraepithelial Neoplasia (FLAN) (FLAN)
Study Overview
Status
Intervention / Treatment
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 procedure has not previously been formally assessed.
HIV and negative positive MSM in whom HSIL has been detected will form the study population, as HSIL is prevalent in these patients and intervention is felt to be indicated. Functional assessments will be carried out prior to initial treatment and then repeated six months after laser ablation therapy. The structure, function and sensitivity of the anal canal will be evaluated using endoanal ultrasound, high-resolution anal manometry and anal mucosal electrosensitivity measurements respectively. Patient-reported outcomes will be assessed using questionnaires and semi-structured interviews at baseline, 4 weeks and 6 months post-treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tamzin Cuming, FRCS
- Phone Number: 02085105555
- Email: Tamzin.cuming@nhs.net
Study Contact Backup
- Name: Christine Inwang, MSc
- Phone Number: 02085105134
- Email: christine.mitchell-inwang@nhs.net
Study Locations
-
-
-
London, United Kingdom, E9 6SR
- Recruiting
- Homerton University Hospital NHS Foundation Trust
-
Contact:
- Tamzin Cuming, FRCS, MBBS
- Phone Number: 02085105555
- Email: tamzin.cuming@nhs.net
-
Contact:
- Mayura Nathan, FRCS
- Phone Number: 7979 02085105555
- Email: mayura.nathan@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anorectal function post anal laser
Intervention: Device: laser |
functional studies before and after anal laser ablation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manometric indices
Time Frame: Six months
|
Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anal mucosal sensitivity
Time Frame: 6 months
|
Changes in sensitivity as measured against patients own pre treatment perception
|
6 months
|
Endoanal ultrasound abnormalities
Time Frame: 6 months
|
Changes in endoanal ultrasound abnormalities compared to pre-treatment findings
|
6 months
|
Physical and psychological well-being
Time Frame: 4 weeks 6 months
|
Qualitative subjective physical and psychological well-being 4 weeks and 6 months after procedure of laser mucosal ablation of AIN
|
4 weeks 6 months
|
Patient reported outcomes
Time Frame: 6 months
|
Patient reported outcomes, particularly with regard to sexual function and bowel function
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Tamzin Cuming, FRCS, Homerton University Hospital NHS Trust
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Anus Diseases
- Neoplasms
- Pain, Postoperative
- Carcinoma in Situ
- Anus Neoplasms
- Fecal Incontinence
Other Study ID Numbers
- R&DCL1403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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