Evidence map›Paper›PMID 39346733›Full record

ArticleFrontiers in oncology2024

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.

Anna-Jasmina Donaubauer, Benjamin Frey, Manuel Weber, Moritz Allner, Christoph Vogl, Omar Almajali, Lukas Kuczera, Henriette Tamse, Matthias Balk, Sarina Müller and 10 more

Abstract read
In one paragraph

Article in Frontiers in oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Anna-Jasmina Donaubauer *Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Benjamin Frey *Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Manuel WeberComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Moritz AllnerComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Christoph VoglComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Omar AlmajaliComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Lukas KuczeraComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Henriette TamseComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Matthias BalkComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Sarina MüllerComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Markus EcksteinComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Lilli ZülchTranslational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Lia MoggeTranslational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Thomas WeissmannDepartment of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Rainer FietkauDepartment of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Marco KestingComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Heinrich IroComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Udo S GaiplTranslational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Markus HechtDepartment of Radiotherapy and Radiation Oncology, Saarland University Medical Center, Homburg, Saar, Germany.
Antoniu-Oreste GostianComprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 radio-chemotherapy (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.

Indexed as

HNSCCimmune monitoringimmunological biomarkerliquid biopsyprospective clinical trial

Identifiers

PMID39346733
PMCPMC11427411

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.