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Immune Biomarker Study for Head and Neck Cancer

Recruitingn/aAges 18 Years - anyAllUniversity of Erlangen-Nürnberg Medical School
NCT05375266 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Age ≥ 18 years * Cognitive ability of the patients to understand the meaning and purpose of the study and agree to it Exclusion Criteria: * 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 * Patients who are legally patronized * Patients who are not eligible for participation in the study due to language barrier
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What it tests

  • Sampling
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Where

3 sites
ENT - Head and Neck Surgery Department
Erlangen, Germany
Maxillo-Facial-Surgery Department
Erlangen, Germany
Radiation Oncology Department
Erlangen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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