ANALYSIS OF METHODOLOGICAL CHALLENGES IN DESIGNING RESEARCH PROTOCOLS FOR EPIGENETIC DIAGNOSTIC STUDIES OF OROFACIAL CANCER IN NIGERIA

Cancer remains a disease burden with high morbidity and mortality rates worldwide, particularly in low- and middle-income countries. Orofacial cancer including oral squamous cell carcinoma (OSCC) makes up a large proportion of head and neck cancers which are often diagnosed late, are aggressive with high recurrence rate and cost of treatment and poor survival rate. Although clinical examination, histopathology, imaging, cytology, and immunohistochemistry remain conventional methods for cancer diagnosis, recent advances in molecular oncology have provided researchers a new interest in epigenetic biomarkers for early detection of cancer, risk assessment, prognosis and individualized therapy. Epigenetic alterations such as DNA methylation, histone modification, chromatin remodeling and deregulation of non-coding RNAs have been shown to play key roles in oral cancer development. Development of robust study designs for epigenetic diagnostic research on orofacial cancer remains limited by ethical, methodological, infrastructural, economic, regulatory and bioinformatics challenges in Nigeria. This review aims to look at the methodological considerations for epigenetic diagnostic research and explore challenges affecting study protocols in Nigeria. This review analysed the methodological framework necessary for epigenetic diagnostic studies of orofacial cancer and assessed the challenges impacting protocol development in Nigeria, utilising publicly accessible literature from sources including PubMed, Google Scholar, institutional reports, policy documents, and other pertinent scholarly materials. Suggestions on how to improve study quality, reproducibility, local relevance and translational research were also highlighted. Strategies to improve epigenetic diagnostic research in Nigeria may include the development of improved ethical review guidelines, investment in molecular diagnostic laboratory infrastructure, establishment of biospecimen collection and storage standard operating procedures, bioinformatics development, conduct of local validation studies and determination of sustainable funding avenues.