Study of immune biomarkers in head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the prognostic value of immune biomarkers in patients with newly diagnosed non-metastatic head and neck cancer. It will analyze both intratumoral and systemic immune responses, correlating local tumor immunology with systemic immune status through blood samples. Additionally, tumor organoids will be created for further biological analysis, with the goal of developing a prognostic score based on immune characteristics. The study focuses on understanding how these immune markers can inform treatment decisions and patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• ENT - Head and Neck Surgery Department
  Erlangen, Bavaria, Germany Recruiting
• Maxillo-Facial-Surgery Department
  Erlangen, Bavaria, Germany Recruiting
• Radiation Oncology Department
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Manuel Weber, PD Dr. med. Dr. med. dent. — Maxillo-facial-surgery, University of Erlangen-Nurnberg
• Study coordinator: Antoniu-Oreste Gostian, PD Dr. med.
• Email: antoniu-oreste.gostian@uk-erlangen.de
• Phone: +49 9131 85-33156

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.