COrSIcA: Disease Measurement

Anal cancer can be prevented through detection and treatment of a recognised precancerous lesion, known as anal intra-epithelial neoplasia (AIN), specifically the anal high-grade squamous intra-epithelial lesion (aHSIL) subtype. Assessment of changes in disease burden is an important feature in the clinical evaluation of a treatment. Existing trials in aHSIL have predominantly used disease response outcomes based on histological and cytological changes to measure the effects of treatment. Several limitations to this approach have been identified. Lesion characteristics such as lesion size and number represent potential indicators of disease response to treatment and might overcome some of the limitations. We aim to develop a disease measurement instrument capable of describing disease burden such that it can be used to evaluate disease response to treatment in addition to histological and cytological based measurements further strengthening the quality of disease response outcomes. The disease measurement instrument will be developed over 4 stages: 1. A meeting of AIN experts to determine a longlist of lesion measurement items capable of capturing disease burden; 2. A series of disease assessments will be undertaken in participants known to have aHSIL to assess disease burden using the measurement items identified in stage 1; 3. Data analysis to determine the best performing measurement items and comprise a disease measurement instrument; 4. Pilot-testing of the proposed disease measurement instrument. Two trained disease assessors (experienced clinicians familiar with the assessment of anal intraepithelial lesions) will assess disease burden per participant. Disease burden will also be captured photographically. We will undertake disease assessments on 20-30 participants. By analysing the results of the clinician assessments and digital analysis of the photographic representation of disease burden, we will be able to determine the most acceptable, feasible, reliable and reproducible ways of measuring disease burden and use these to inform a disease measurement instrument.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

PARTICIPANTS:

• Adults \> 18 years of age.

PATHOLOGY:

Absolute:

* Histologically proven high-grade squamous intra-epithelial neoplasia of the anal canal, peri-anus or both within the last 12 months.
* Lesions suspicious for ongoing aHSIL visible to the naked eye.

Optional:

* Co-existing pathology, such as Low-grade anal squamous intra-epithelial neoplasia (aLSIL), condyloma, haemorrhoids, anal fissure, and fistula in ano.
* Changes present from previous treatment, such as scar tissue, strictures, and irradiation changes from previous radiotherapy.

INTERVENTIONS:

• No specific treatment inclusion.

Exclusion Criteria:

PARTICIPANTS:

* Unable to give informed consent.
* Too unwell to tolerate anaesthetic (general or spinal) lasting approximately up to 60 minutes.
* \*Known allergy or sensitivity to 5% acetic acid and or Lugol's Iodine.

PATHOLOGY:

* Concurrent squamous cell carcinoma or the anus.
* Low-grade anal squamous intra-epithelial neoplasia (aLSIL) only.

INTERVENTIONS:

• No specific treatment exclusions.

\*Once HRA available