Anus CancerFLANNCT04109573
Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
A study testing high resolution anal manometry in people with Anus Cancer and Fecal Incontinence, run by Homerton University Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Anus Cancer, Fecal Incontinence, Anal Intraepithelial Neoplasia
- What is being tested?
- high resolution anal manometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Homerton University Hospital NHS Foundation Trust
London, E9 6SR
Tamzin Cuming, FRCS, MBBS, 02085105555, tamzin.cuming@nhs.net
Mayura Nathan, FRCS, 02085105555 ext. 7979, mayura.nathan@nhs.net
About this study
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.
Read the 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.
- Being tested
- high resolution anal manometry
- Keywords
- laser ablation, anal intraepithelial neoplasia, AIN, fecal incontinence, anal function
- Medical subject headings
- Anus Neoplasms, Fecal Incontinence, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high resolution anal manometryProcedure or surgery
Also called endoanal ultrasound, gastrointestinal physiology
functional studies before and after anal laser ablation
| Study group | Role | What they receive |
|---|---|---|
| Anorectal function post anal laser | Experimental | Intervention:
Device: laser Receives: Procedure: high resolution anal manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manometric indices
Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values
Measured: Six months
Secondary outcomes (4)
Anal mucosal sensitivity
Changes in sensitivity as measured against patients own pre treatment perception
Measured: 6 months
Endoanal ultrasound abnormalities
Changes in endoanal ultrasound abnormalities compared to pre-treatment findings
Measured: 6 months
Physical and psychological well-being
Qualitative subjective physical and psychological well-being 4 weeks and 6 months after procedure of laser mucosal ablation of AIN
Measured: 4 weeks 6 months
Patient reported outcomes
Patient reported outcomes, particularly with regard to sexual function and bowel function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Mar 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anus CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Homerton University Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- Tamzin Cuming, FRCS, Study director, Homerton University Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109573
- Sponsor's protocol ID
- R&DCL1403
- Acronym
- FLAN
- Status last verified
- Aug 2021
- First submitted
- 21 Apr 2016
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
- ClinicalTrials.gov ID
- NCT04109573
- Acronym / sponsor ID
- FLAN / R&DCL1403
- Keywords
- laser ablation, anal intraepithelial neoplasia, AIN, fecal incontinence, anal function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Homerton University Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anorectal function post anal laser | Experimental | Procedure: high resolution anal manometryIntervention: Device: laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high resolution anal manometryAlso: endoanal ultrasound, gastrointestinal physiologyfunctional studies before and after anal laser ablation | Procedure or surgery | Anorectal function post anal laser |
Primary outcome
Manometric indices
Time frame: Six months
Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values
4 secondary outcomes
Anal mucosal sensitivity
Time frame: 6 months
Endoanal ultrasound abnormalities
Time frame: 6 months
Physical and psychological well-being
Time frame: 4 weeks 6 months
Patient reported outcomes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamzin Cuming, FRCS study director
Homerton University Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high resolution anal manometry in people with Anus Cancer and Fecal Incontinence, run by Homerton University Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamzin Cuming, FRCS (02085105555, Tamzin.cuming@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manometric indices (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.