Trans-oral brush biopsies and quantitative PCR for EBV DNA detection and screening of nasopharyngeal carcinoma in an Indonesian population.
The incidence of nasopharyngeal carcinoma in Indonesia is estimated at 6 per 100,000, leading to 15,000 new cases per year. This, however, might be an underestimation due to insufficient cancer registries, and patients not being diagnosed with NPC in more rural areas.
Patients with nasopharyngeal carcinoma (NPC) are often diagnosed when the tumour has already progressed to an advanced stage. The disease, when diagnosed in the early stages, is readily treated with radiotherapy.
One of the reasons for this delayed diagnosis is the poor availability of NPC diagnostic services. If validated in this population, the noninvasive trans-oral swab could be used in a community setting to support the urgent referral of patients to specialist ENT surgery and head and neck cancer clinics, and hopefully result in earlier diagnoses.
To evaluate a newly developed noninvasive ambulatory, quantitative polymerase chain reaction (Q-PCR) Epstein-Barr virus (EBV) DNA detection and screening system (NP Screen™) for nasopharyngeal carcinoma (NPC) in an Indonesian population.
Correlation of the nasopharyngeal epithelial EBV-DNA levels and clinical findings by nasopharyngoscopy and final pathologic diagnosis of NPC with subsequent biopsy (gold standard).
Multicenter ENT/Head and Neck clinics in Yogyakarta City (Dr. Sardjito Hospital) and District General Hospitals (e.g. Wonosari District Hospital) in Yogyakarta Province.
A single-use trans-oral brush will be used for rapid, nontraumatic nasopharyngeal (NP) epithelial cells DNA harvest in 200-300 Indonesian patients, combined with a preservation agent and shipping kit for remote, real-time Q-PCR EBV DNA determinations.
All 200-300 patients will have NP brushings using NP Screen in an ambulatory environment and the study shall investigate the sensitivity and specificity for NP Screen in detecting NPC in an Indonesian population with the aim to introduce this noninvasive, sensitive, specific detection method in the fourth biggest country in the world.
Collaborative project between University College London, UK; Gadjah Mada University, Yogyakarta City, Indonesia; Netherlands Cancer Institute, Netherlands; the company NP Screen (Toronto); and the Association for the Global Advancement of ENT Surgery and Head and Neck Cancer Research (AGA-ENT) .
Principal Investigators: Matt Lechner, MD PhD (UCL Cancer Institute, London, UK) and Sagung Indrasari, MD (Dr. Sardjito Hospital, Yogyakarta, Indonesia)
Study coordinator: Liam Sutton (MD student, UCL Cancer Institute, London, UK)