Immune Biomarker Study for Head and Neck Cancer

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.

Conditions

• Head and Neck Cancer
• Oral Cavity Cancer
• Oropharyngeal Cancer
• Hypopharyngeal Cancer
• Laryngeal Cancer

Interventions

OTHER

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.

Sponsors & Collaborators

• University Hospital Erlangen

  collaborator OTHER

• University Hospital Regensburg

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• University of Erlangen-Nürnberg Medical School

  lead OTHER

Principal Investigators

• Antoniu-Oreste Gostian, PD Dr. med. · ENT - Head and Neck Surgery Department, University of Erlangen-Nurnberg

• Markus Hecht, PD Dr. med. · Radiation Oncology, University of Erlangen-Nurnberg

• Manuel Weber, PD Dr. med. Dr. med. dent. · Maxillo-facial-surgery, University of Erlangen-Nurnberg

• Udo Gaipl, Prof. Dr. rer. nat. habil. · Translational Radiobiology, University of Erlangen-Nurnberg

• Benjamin Frey, PD Dr.-Ing. Dr. habil. med. · Translational Radiobiology, University of Erlangen-Nurnberg

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-16

Primary Completion

2026-03-31

Completion

2027-03-31

Countries

• Germany

Study Locations