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An overview of clinical trials in anal cancer 1999-2024
D Verschoor1, E S L Pedersen1, A Tardit1
1Department of Clinical Research, University of Bern, Bern, Switzerland.
Background:
Anal cancer (AC) is an uncommon malignancy. Clinical trials are crucial for improving prevention and treatment, but conducting research is challenging in this condition. This paper provides an overview of registered clinical trials in the prevention and treatment of AC between 1999 and 2024.
Materials And Methods:
AC trials were identified from the two main global trial databases: the International Clinical Trials Registry Platform and clinicaltrials.gov. Trials were categorized based on context and disease extent: pre-AC (pre-cancerous states), early AC (localized, curable disease), and advanced AC (metastatic and/or incurable disease).
Results:
There were 251 trials identified: 55 pre-AC, 100 early AC, and 96 advanced AC. Only 10% were phase III studies. The number of trials increased over the 25-year period, particularly advanced AC trials since 2015. Trials listed as active totaled 109, of which 54% were actively recruiting. Most trials were conducted in high-income countries and only 38 were multinational. Underrepresented groups were immunosuppressed patients. Only one-third of trials were industry-sponsored, lower than most other cancer types.
Conclusions:
Although there has been a steady increase in AC trials, many research questions remain. Disparities are clear, with few trials in low-income countries, where the burden of disease is likely to grow as a consequence of less access to human papillomavirus (HPV) vaccination, which is likely to prevent disease. Clinical trials in AC rely mainly on academic consortia.
Insights
Clinical trials for anal cancer (AC) are increasing, but research gaps persist. Most studies focus on early-stage disease, with limited trials in low-income nations and underrepresented patient groups.
Area of Science:
- Oncology
- Clinical Research
- Epidemiology
Background:
- Anal cancer (AC) is a rare malignancy.
- Clinical trials are vital for advancing AC prevention and treatment.
- Research in AC faces unique challenges.
Purpose of the Study:
- To provide a comprehensive overview of registered clinical trials for anal cancer.
- To analyze trends in AC clinical trials from 1999 to 2024.
- To identify disparities and research gaps in AC studies.
Main Methods:
- Searched International Clinical Trials Registry Platform and clinicaltrials.gov.
- Categorized trials into pre-AC, early AC, and advanced AC.
- Analyzed trial phase, recruitment status, location, sponsorship, and patient populations.
Main Results:
- 251 trials identified: 55 pre-AC, 100 early AC, 96 advanced AC.
- Trial numbers increased over 25 years, with a rise in advanced AC trials since 2015.
- Most trials were in high-income countries, few were multinational, and industry sponsorship was low.
Conclusions:
- Despite increased trial activity, significant research questions remain for anal cancer.
- Disparities exist, with few trials in low-income countries and underrepresented groups.
- Academic consortia largely drive AC clinical trial research.
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