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Immune Biomarker Study for Head and Neck Cancer
Sponsor: University of Erlangen-Nürnberg Medical School
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1100
Start Date
2022-05-16
Completion Date
2027-03-31
Last Updated
2023-05-17
Healthy Volunteers
No
Conditions
Interventions
Sampling
This is an observational study. Consequently, study participation does not alter the therapy of the treated disease. Blood will be drawn from patients at several time points during and after radiotherapy (RT) and therapy with immune checkpoint inhibitor (ICI) for detailed immunomonitoring of the patients. In addition, faeces and sputum of the patients for microbiomic and metabolomic measures will be collected. Whenever possible, adequate tissue samples are taken from the center of the tumor and a biopsy is taken from the edge of the tumor including the adjacent mucosa in the nearby area without affecting the pathological assessment (study group). Blood, faeces and sputum will be taken from patients of the control group prior to surgery. After surgery, only blood will be taken.
Locations (3)
ENT - Head and Neck Surgery Department
Erlangen, Bavaria, Germany
Maxillo-Facial-Surgery Department
Erlangen, Bavaria, Germany
Radiation Oncology Department
Erlangen, Bavaria, Germany