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ORIGINAL RESEARCH article

Front. Oncol.
Sec. Head and Neck Cancer
Volume 14 - 2024 | doi: 10.3389/fonc.2024.1451035
This article is part of the Research Topic Multi-Omics in Head and Neck Cancer: Unveiling Immunological Biomarkers for Therapy View all articles

Defining intra-tumoral and systemic immune biomarkers for locally advanced head-and-neck cancer -Detailed protocol of a prospective, observatory multicenter trial (ImmunBioKHT) and first results of the immunophenotyping of the patients' peripheral blood

Provisionally accepted
Anna-Jasmina Donaubauer Anna-Jasmina Donaubauer 1*Benjamin Frey Benjamin Frey 1*Manuel Weber Manuel Weber 2Moritz Allner Moritz Allner 3Christoph Vogl Christoph Vogl 2Omar Almajali Omar Almajali 3Lukas Kuczera Lukas Kuczera 3Henriette Tamse Henriette Tamse 3Matthias Balk Matthias Balk 3Sarina Mueller Sarina Mueller 3Markus Eckstein Markus Eckstein 4Lilli Zülch Lilli Zülch 1Lia Mogge Lia Mogge 1Thomas Weissmann Thomas Weissmann 5Rainer Fietkau Rainer Fietkau 5Marco R. Kesting Marco R. Kesting 2Heinrich Iro Heinrich Iro 3Udo S. Gaipl Udo S. Gaipl 1Markus Hecht Markus Hecht 6Antoniu-Oreste Gostian Antoniu-Oreste Gostian 7
  • 1 Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Erlangen, Germany
  • 2 Department of Oral and Cranio-Maxillofacial Surgery, Uniklinikum Erlangen, Erlangen, Germany
  • 3 Department of Otolaryngology - Head & Neck Surgery, Uniklinikum Erlangen, Erlangen, Germany
  • 4 Institute of Pathology, Uniklinikum Erlangen, Erlangen, Germany
  • 5 Department of Radiation Oncology, Uniklinikum Erlangen, Erlangen, Germany
  • 6 Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center, Homburg/Saar, Homburg/Saar, Germany
  • 7 Department of Otorhinolaryngology, Merciful Brothers Hospital St. Elisabeth, Straubing, Straubing, Germany

The final, formatted version of the article will be published soon.

    The approval and effectiveness of immune checkpoint inhibitors in head-and-neck squamous cell carcinoma (HNSCC) highlights the role of the immune system in this tumor entity. HNSCCs not only interacts with the immune system in the tumor tissue, but also induce systemic effects that may be additionally influenced by further factors such as the microbiome. Nonetheless, reliable immunological biomarkers that predict treatment response and outcome in HNSCC patients are lacking. The currently available biomarkers are mainly limited to analyses from tumor biopsies, while biomarkers from liquid biopsies, such as peripheral blood are not well-established. Thus, the here presented trial aims to identify interactions of intra-tumoral and systemic immune responses and to define prognostic immune signatures. Consequently, not only samples from the tumor tissue, but also from peripheral blood and the microbiome will be studied/are being evaluated and correlated with the clinical outcome.In this prospective, multi-center trial, 1000 HNSCC patients and 100 patients in the control cohort with non-tumor head-and-neck surgery will be enrolled. The local immune status from of the tumor and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analyzed before and after surgery and after the adjuvant and definitive radiochemotherapy (RCT). Clinical baseline characteristics and outcome will additionally be collected. Data mining and modelling approaches will finally be applied to identify interactions of local and systemic immune parameters and to define prognostic immune signatures based on the evaluated immune markers.Approval from the institutional review board of the Friedrich-Alexander-Universität Erlangen-Nürnberg was granted in December 2021 (application number 21-440-B). By now, 150 patients have been enrolled in the intervention cohort. The results will be disseminated to the scientific audience and the general public via presentations at conferences and publication in peer-reviewed journals.

    Keywords: HNSCC, liquid biopsy, immune monitoring, Immunological biomarker, Prospective clinical trial

    Received: 18 Jun 2024; Accepted: 27 Aug 2024.

    Copyright: © 2024 Donaubauer, Frey, Weber, Allner, Vogl, Almajali, Kuczera, Tamse, Balk, Mueller, Eckstein, Zülch, Mogge, Weissmann, Fietkau, Kesting, Iro, Gaipl, Hecht and Gostian. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Anna-Jasmina Donaubauer, Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Erlangen, Germany
    Benjamin Frey, Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Erlangen, Germany

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