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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032186
Enrollment
100
Registered
2023-07-03
Start date
2019-12-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Malignant neoplasm of the oral cavity, oropharynx, hypopharynx, larynx C14.8 C10.8 C32.8 C13.8

Interventions

Group 1: patients with Head neck cancer

Sponsors

Universitätsklinikum Jena, Klinik für Hals-, Nasen- und Ohrenheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: - Salivary gland malignancies -Lack of consent

Design outcomes

Primary

MeasureTime frame
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. Examination of tissue and saliva samples of recurrences and determination the sensitivity and specificity of the biomarkers. 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

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

Countries

China, Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026