title: Soluble CD44 is a potential marker for the early detection of head and neck cancer.
abstract: BACKGROUND
  Head and neck squamous cell carcinoma (HNSCC) is a devastating and deadly disease, largely because it is diagnosed in late stage. Cure rates, currently at 50%, could increase to >80% with early detection. In this study, we evaluate soluble CD44 (solCD44) as an early detection tool for HNSCC by determining whether it reliably distinguishes HNSCC from benign disease of the upper aerodigestive tract.
  
  
  METHODS
  We carried out the solCD44 ELISA on oral rinses from 102 patients with HNSCC and 69 control patients with benign diseases of upper aerodigestive tract to determine the sensitivity and specificity of the test for differentiating HNSCC from benign disease. Furthermore, we did a pilot study using methylation-specific PCR primers on oral rinses from 11 HNSCC patients with low solCD44 levels and 10 benign disease controls.
  
  
  RESULTS
  Mean salivary solCD44 levels were 24.4 +/- 32.0 ng/mL for HNSCC patients (range, 0.99-201 ng/mL) and 9.9 +/- 16.1 ng/mL (range, 0.73-124 ng/mL) for the patients with benign disease (P < 0.0001). Depending on cutoff point and HNSCC site, sensitivity ranged from 62% to 70% and specificity ranged from 75% to 88%. Nine of 11 HNSCC and 0 of 10 controls with low solCD44 levels showed hypermethylation of the CD44 promoter.
  
  
  CONCLUSIONS
  SolCD44 is elevated in the majority of HNSCC and distinguishes cancer from benign disease with high specificity. Whereas the solCD44 test lacks sensitivity by itself, methylation status of the CD44 gene seems to complement the solCD44 test. Our pilot data indicate that, together, these markers will detect HNSCC with very high sensitivity and specificity.
authors.affiliation: University of Miami/Sylvester Comprehensive Cancer Center, USA. efranzman@med.miami.edu
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Franzmann
authors.forename: Erika P
authors.initials: EP
authors.lastname: Reategui
authors.forename: Felipe
authors.initials: F
authors.lastname: Pedroso
authors.forename: Francisco G
authors.initials: FG
authors.lastname: Pernas
authors.forename: Baris M
authors.initials: BM
authors.lastname: Karakullukcu
authors.forename: Kermit L
authors.initials: KL
authors.lastname: Carraway
authors.forename: Kara
authors.initials: K
authors.lastname: Hamilton
authors.forename: Rakesh
authors.initials: R
authors.lastname: Singal
authors.forename: W Jarrard
authors.initials: WJ
authors.lastname: Goodwin
mesh_terms: D014408:Biomarkers, Tumor / Q000378:metabolism*; D002294:Carcinoma, Squamous Cell / Q000378:metabolism* / Q000473:pathology; D016022:Case-Control Studies; D019175:DNA Methylation; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006258:Head and Neck Neoplasms / Q000378:metabolism* / Q000473:pathology; D006801:Humans; D018960:Hyaluronan Receptors / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000378:metabolism / Q000473:pathology; D009367:Neoplasm Staging; D010865:Pilot Projects; D011379:Prognosis; D012463:Saliva / Q000378:metabolism; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; C497483:CD44 protein, human; D018960:Hyaluronan Receptors