Immune markers in tumor and blood for head and neck cancer
Studies immune markers in people with new head and neck cancer.
Plain-language title generated from the registry record
Registry title: Immune Biomarker Study for Head and Neck Cancer
Key facts
- Where
- Erlangen, GermanySee the 3 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly found squamous cell cancer of the mouth, throat or voice box (stage UICC II-IVB), and for a control group without cancer who need ear, nose or jaw surgery. Samples of blood, saliva and stool are taken.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Study group: first diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx, stage UICC II-IVB. Control group: diseases other than cancer, with an indication for ear, nose or maxillofacial surgery.
Main reasons for not taking part
- Distant metastases or a second cancer at the time of diagnosis
- Tumours where a sample cannot be taken without affecting the further pathology assessment
- Present drug abuse
- Unable or unwilling to follow the protocol and receive treatment as planned
- Legally under guardianship, or cannot take part because of a language barrier
Read by machine on 9 November 2026.
Where in Germany
- ENT - Head and Neck Surgery DepartmentErlangen, GermanyTaking people
- Maxillo-Facial-Surgery DepartmentErlangen, GermanyTaking people
- Radiation Oncology DepartmentErlangen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Erlangen-Nürnberg Medical School
- Trial code
- NCT05375266
- Record updated
- 17 May 2023
- Original description
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.Read full original descriptionShow less
Immune Biomarker Study for Head and Neck Cancer
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.
Inclusion: 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: Present drug abuse; 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; 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.