NCT05858021

COrSIcA: Disease Measurement

Status unknown Last updated 15 May 2023

What this trial tests

trial testing Physical examination in Anal Intraepithelial Neoplasia in 30 participants. Status unknown.

Timeline

3 July 2023

Primary endpoint
2 July 2024

2 July 2025

Quick facts

Lead sponsor	David Finch
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	30
Start date	3 July 2023
Primary completion	2 July 2024
Estimated completion	2 July 2025

Drugs / interventions tested

• Physical examination

Conditions studied

• Anal Intraepithelial Neoplasia — all drugs for Anal Intraepithelial Neoplasia →
• Anal High-grade Squamous Intraepithelial Lesion — all drugs for Anal High-grade Squamous Intraepithelial Lesion →
• Anal HSIL — all drugs for Anal HSIL →

Sponsor

David Finch

Who can join

18 and older, any sex, with Anal Intraepithelial Neoplasia or Anal High-grade Squamous Intraepithelial Lesion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.