Raman Spectroscopy in Head and Neck Oncology

Raman Spectroscopy in Head and Neck Oncology - Raman Spectroscopy in Head and Neck Oncology

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38366

Enrollment

Registered

2012-03-15

Start date

2012-05-02

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC) tumor

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary outcomes are the characteristic Raman spectra of the tissue structures and cell types within normal and malignant mucosa from the oral cavity (in particular the edge of the tongue and the floor of the mouth), as a reflection of the molecular/ biochemical composition of these tissues.	—

Secondary

Measure	Time frame
• Determine what the difference is in the molecular/ biochemical fingerprints between the normal-looking mucosa adjacent to the tumor and the normal mucosa of the contralateral side of the oral cavity. • Determine what the difference is in the molecular/ biochemical fingerprints between normal and malignant mucosa of the oral cavity. • Determine what the difference is in the molecular/ biochemical fingerprints between different patients (interpatient variance). • Determine what the sensitivity and specificity of Raman spectroscopy is, compared to the gold standard (histological assessment). • Build a multivariate diagnostic model that can distinguish between normal and malignant mucosa from the oral cavity	—

Measure

Time frame

• Determine what the difference is in the molecular/ biochemical *fingerprints* between the normal-looking mucosa adjacent to the tumor and the normal mucosa of the contralateral side of the oral cavity. • Determine what the difference is in the molecular/ biochemical *fingerprints* between normal and malignant mucosa of the oral cavity. • Determine what the difference is in the molecular/ biochemical *fingerprints* between different patients (interpatient variance). • Determine what the sensitivity and specificity of Raman spectroscopy is, compared to the gold standard (histological assessment). • Build a multivariate diagnostic model that can distinguish between normal and malignant mucosa from the oral cavity

—

Countries

Netherlands

Outcome results