Development of a method for secondary and tertiary prevention of head and neck tumors

Recruiting

• Conditions: C14.8; Malignant neoplasm of the oral cavity, oropharynx, hypopharynx, larynx; C10.8; C32.8; C13.8; Overlapping lesion of lip, oral cavity and pharynx; Overlapping lesion of oropharynx; Overlapping lesion of larynx; Overlapping lesion of hypopharynx

• Registration Number: DRKS00032186
• Lead Sponsor: niversitätsklinikum Jena, Klinik für Hals-, Nasen- und Ohrenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients
- with head and neck tumours
- Men and women who come to the scene for the clarification of symptoms with suspicion for malignancy in the head and neck area in the otolaryngology clinic,
- Primary tumors and recurrent tumors
- HPV-independent (HPV+ and HPV-)
- Age = 18 years
Controls:
- Patients without head and neck cancer who have undergone surgery
tissue is obtained from the oropharynx, e.g. with recurrent
Tonsillitis who present for tonsillectomy

Exclusion Criteria

- Salivary gland malignancies
-Lack of consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the sensitivity and specificity of selected biomarkers for the detection of head and neck tumors using tissue and non-invasive samples (smear and saliva) of the primary tumor using probe-based multiplex assay.<br>Examination of tissue and saliva samples of recurrences and determination<br>the sensitivity and specificity of the biomarkers.<br>Analysis of the biomarkers in saliva samples from the follow-up in order to be able to follow an early detection of the recurrences by the markers.

Secondary Outcome Measures

Name	Time	Method
Investigation of sensitivity and specificity of tumor markers in the blood:<br>Analysis of the compliance rate of the detected markers between<br>Tissue and saliva samples in the primary tumor as well as recurrences that occur.<br>Determination of sensitivity and specificity for individual marker regions and<br>their combinations for the detection of head and neck tumors:<br>Positivity rates of biomarkers in subgroups