Immune Biomarker Study for Head and Neck Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

The aim of this prospective non-interventional multi-center trial is to study the prognostic value of intratumoral and systemic immune biomarkers in newly diagnosed non-metastatic head and neck cancer. Furthermore, the local immunological processes in the tumor will be correlated with the systemic immune status determined in the peripheral blood to identify prognostic immune signatures. In addition, tumor organoids will be generated ex vivo for functional biological analyses. The main objective is to create a prognostic score determined by clusters based on tumor immunologic criteria.

Eligibility criteria

Qualifiers

Initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC II-IVB (study group)

Diseases other than malignant diseases (patients with the indication for surgery of the ear, nose nose or maxillofacial surgery) (control group)

Absence of a currently existing or previous malignant disease regardless of the anatomical localization (control group)

Agreement of the patients for sampling blood, saliva and stool as well as consent to the preservation of all samples for further study purposes

Disqualifiers

Distant metastases and / or simultaneous secondary carcinoma at the time of diagnosis (= inclusion date)

Carcinomas in which it is (likely) impossible to take a sample without interfering with the further pathological assessment

Present drug abuse

Patients who are unable or unwilling to behave and receive treatment according to protocol

Trial design

Treatments tested in this trial

  • Sampling

Treatment groups

1,100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Erlangen-Nürnberg Medical School

Lead sponsor

University Hospital Erlangen

Collaborator

University Hospital Regensburg

Collaborator

University Hospital Augsburg

Collaborator