Anal Intraepithelial Neoplasia and Anal Squamous Cell Carcinoma

NCT05835960 | Unknown

• 1 other identifier: 234715
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study involving exome sequencing and immune profiling of matched tissue and blood samples from patients with both high-grade squamous intraepithelial lesions and anal squamous cell carcinoma. This is a collaborative project between Imperial College London and the Institute of Cancer Research (ICR), investigating the genetic predeterminants for the progression of anal HSIL to SCC as well as the immunogenetic profile of these conditions will be beneficial for risk stratification (with respect to identifying those individuals with anal HSIL most likely to progress to invasive disease), the identification of potential new drug targets and will add to our understanding of how the tumour microenvironment may influence treatment response and disease recurrence of both anal HSIL and SCC.

Conditions

Anal Cancer; Anal Squamous Intraepithelial Neoplasia

Keywords

Anal Cancer; Early Diagnosis; Anal Squamous Intraepithelial Lesion; Biomarker; HPV; Treatment response

Outcome Measures

Primary Outcomes (2)

• Identify prognostic biomarkers with respect to anal SCC disease progression and treatment response.

  Genomic and immune biomarkers

  1 year

• Establish the feasibility of immune analysis and NGS in informing patient treatment decisions.

  Pilot study, with low patient numbers

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HPV driven AIN 3 and anal SCC.

You may qualify if:

• Males or females, with or without HIV over the age of 18 years at the time of recruitment.
• Patients with either:
• A previous complete set of formalin fixed tissue samples of all stages of AIN and anal SCC.
• A new diagnosis of AIN3 and are about to undergo Anal mapping.
• A new diagnosis of Anal Squamous Cell Carcinoma and are about to undergo an Examination under Anaesthetic.

You may not qualify if:

• Patients without mental capacity to consent.
• Patients less than 18 years old.
• Patients with anal pathology which is not HPV driven AIN/SCC.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London- Chelsea and Westminster NHS Foundation Trust

London, SW10 9NH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, FFPE and frozen biopsies of anal high-grade squamous intraepithelial lesions, FFPE and frozen biopsies of anal squamous cell carcinoma, normal control tissue.

MeSH Terms

Conditions

Anus Neoplasms; Disease

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Micol Lupi, BSc, MBBS, MRCS

CONTACT

020 3315 8000; m.lupi22@imperial.ac.uk

Christos Kontovounisios, MD, PhD, FACS, FRCS

CONTACT

020 3315 8000; c.kontovounisios@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: April 28, 2023
• Study Start: April 1, 2019
• Primary Completion: April 30, 2024
• Study Completion: October 1, 2024
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

GB (1)