| Background: Every year in the United States of America approximately 30,990 new cases of head and neck squamous cell carcinoma (HNSCC) are diagnosed moreover, 7430 people die from the disease. Early HNSCC exhibits clinical symptoms that are often mistaken as more common benign conditions and it is often asymptomatic until later stages. Because of the challenges to diagnosing HNSCC, a test utilizing a blood sample and analysis with routine laboratory equipment to detect HNSCC would increase the likelihood of early diagnosis of HNSCC. Carcinogenesis is a disease of multi-step genetic dysregulation. In HNSCC, the most commonly amplified and over-expressed gene is p63. There are six different isoforms of p63. The predominant form of p63 expressed in adult epithelial stem cells is the 70 kD non-transactivating isoform of p63, DeltaNp63alpha. When p63 is overexpressed it functions as an oncogene by several mechanisms, including opposition of p53 function. Over-expressed genes lead to increased amounts of protein, which can elicit autoimmune responses. Hypothesis: Patients with HNSCC have serum autoantibodies to DeltaNp63 that will be detected by an ELISA test. Patients without HNSCC will not have serum autoantibodies to DeltaNp63. Materials and Methods: Two hundred sera were examined by ELISA to determine the autoantibodies of DeltaNp63. Results: No statistical difference exists between the mean of OD reading for controls and cancer subjects (p>.05). An optimal cut-off point of 0.409 demonstrates 55% sensitivity and 45% sensitivity between the groups. Conclusion: Lack of statistical difference between the two means suggests that this ELISA failed to detect a proper cut-off point for having a good sensitivity and specificity. Many factors could explain the results one of these factors is the questionable reliability of the indirect ELISA technique according to the laboratory protocol that was used in our experiment. Further investigation using a different ELISA protocol or other immune assay techniques is recommended with new set of sera. |
