Anal Intraepithelial Neoplasia and Anal Squamous Cell Carcinoma.
Research type
Research Study
Full title
The Role of Early Diagnosis and Treatment of Anal Intraepithelial Neoplasia in the Prevention of Anal Squamous Cell Carcinoma: Identifying Prognostic Biomarkers.
IRAS ID
234715
Contact name
Paris Tekkis
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 7 months, 29 days
Research summary
Anal Interstitial Neoplasia (AIN) is a precursor to Anal Squamous Cell Carcinoma (ASCC). It is a Human Papillomavirus linked cancer and has an incidence of between 1-2 per 100,000 per year. It is also associated with HIV and its incidence is increasing due to the higher prevalence of HIV. We expect ASCC to become an increasing burden on cancer services as advanced antiretroviral therapy allows patients with HIV to live longer.
The progression of AIN to ASCC is unpredictable and many patients do not progress from the earliest grades of AIN to ASCC in predictable patterns. AIN exists in 3 grades: AIN1 (low risk of progression), AIN2 (moderate risk of progression) and AIN3 (cancer-in-situ). Understanding the risk factors that predict the progression of AIN will lead to the better treatment of patients with AIN3 at the highest risk of developing anal cancer.
We propose to take tissue samples from patients with AIN and ASCC. We will then compare the genetic profiles to see if we can identify differences that could result in disease progression. This would be achieved by taking biopsies at the same time as planned therapeutic biopsies to limit the inconvenience to patients included in the study as well as prevent harm.
As ASCC is a rare cancer, a direct comparison has never been completed before. However, due to our patient demographics, we have an unusually high yield of diagnoses within our colorectal department and we are in a unique position to be able to complete this research.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0087
Date of REC Opinion
17 Apr 2018
REC opinion
Further Information Favourable Opinion