COrSIcA: Disease Measurement

NCT05858021 | Unknown

• 1 other identifier: 328436
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.A meeting of AIN experts to determine a longlist of lesion measurement items capable of capturing disease burden;
2. 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. 3.Data analysis to determine the best performing measurement items and comprise a disease measurement instrument;
4. 4.Pilot-testing of the proposed disease measurement instrument.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Anal HSIL lesion size and number

  Assessment of changes in disease burden is an important feature in the clinical evaluation of a treatment. They provide a measure of treatment effect. This study will identify lesion characteristics suitable for measuring disease burden and the ways with which these can be acceptably, feasibly, reliably and reproducibly measured. Those features that are most reliably and reproducibly measured will be used to a disease measurement instrument The overall objective is to develop a disease measurement instrument capable of 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. Such an instrument will be applicable to clinical practice in measuring response to treatment.

  60 minutes

Study Arms (1)

Anal HSIL

Participants must have histologically proven diagnosis of Anal HSIL.

Diagnostic Test: Physical examination

Interventions

Physical examination DIAGNOSTIC_TEST

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.

Anal HSIL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Secondary care

You may qualify if:

• 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:

You may not qualify if:

• 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:
• \*Once HRA available

Sponsors & Collaborators

• David Finch: lead
• Lancashire Teaching Hospitals NHS Foundation Trust: collaborator

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

David A Finch, MbChB, BSc

CONTACT

+44 1772 522031; davidfinch-2@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 15, 2023
• Study Start: July 3, 2023
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2025
• Last Updated: May 15, 2023

Record last verified: 2023-05