COrSIcA: Disease Measurement

Summary

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.

Conditions

• Anal Intraepithelial Neoplasia
• Anal High-grade Squamous Intraepithelial Lesion
• Anal HSIL

Interventions

DIAGNOSTIC_TEST

Physical examination

Per participant, two colorectal surgeons, will separately and consecutively each perform disease assessment in accordance with the 'usual' clinical approach (direct visualisation with 'naked eye') with the exception that for each lesion identified they will undertake a series of measurements, obtain photographs of each lesion and record their findings on the proforma provided. Once all lesions identified have been recorded diagrammatically and photographically, EP and PM will confer and collate lesions of suspicion for biopsy. All lesions suspicious for aHSIL will be biopsied/excised in keeping with usual care. During the study period we anticipate HRA to become available within the LTHTR and incorporated into usual care for the clinical assessment of patients with aHSIL. HRA will be used in addition to direct visualisation such that 'usual care' comprises clinical assessment with direct visualisation and HRA.

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• David Finch

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-03

Primary Completion

2024-07-02

Completion

2025-07-02