Raman Spectroscopy in Head and Neck Oncology
Recruiting
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC)tumor10027655
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
• Surgical oncologic procedure because of an untreated SCC of the oral cavity
• Signed informed consent
• Male and female
• Age > 18 years old
• No distant metastasis
Exclusion Criteria
• Another type of tumor in the head and neck region (non SCC)
• Pre-operative treatment (chemotherapy or radiotherapy)
• Presence of distant metastases (M1)
• Patients with HIV, CMV or Hepatitis C
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcomes are the characteristic Raman spectra of the tissue<br /><br>structures and cell types within normal and malignant mucosa from the oral<br /><br>cavity (in particular the edge of the tongue and the floor of the mouth), as a<br /><br>reflection of the molecular/ biochemical composition of these tissues. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• Determine what the difference is in the molecular/ biochemical *fingerprints*<br /><br>between the normal-looking mucosa adjacent to the tumor and the normal mucosa<br /><br>of the contralateral side of the oral cavity.<br /><br>• Determine what the difference is in the molecular/ biochemical *fingerprints*<br /><br>between normal and malignant mucosa of the oral cavity.<br /><br>• Determine what the difference is in the molecular/ biochemical *fingerprints*<br /><br>between different patients (interpatient variance).<br /><br>• Determine what the sensitivity and specificity of Raman spectroscopy is,<br /><br>compared to the gold standard (histological assessment).<br /><br>• Build a multivariate diagnostic model that can distinguish between normal and<br /><br>malignant mucosa from the oral cavity</p><br>