Clinical trial · Observational
Anal Intraepithelial Neoplasia and Anal Squamous Cell Carcinoma
The Role of Early Diagnosis and Treatment of Anal Intraepithelial Neoplasia in the Prevention of Anal Squamous Cell Carcinoma: Identifying Prognostic Biomarkers.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Anal Squamous Intraepithelial Neoplasia | Anal Intraepithelial Neoplasia | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Identify prognostic biomarkers with respect to anal SCC disease progression and treatment response.
- timeFrame
- 1 year
- description
- Genomic and immune biomarkers
- measure
- Establish the feasibility of immune analysis and NGS in informing patient treatment decisions.
- timeFrame
- 1 year
- description
- Pilot study, with low patient numbers
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: * Patients without mental capacity to consent. * Patients less than 18 years old. * Patients with anal pathology which is not HPV driven AIN/SCC.
References
Publications (0)
Data not yet available