ClinConnect ClinConnect Logo
Search / Trial NCT05375266

Immune Biomarker Study for Head and Neck Cancer

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · May 11, 2022

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Immunologic Markers Immunotherapy

ClinConnect Summary

This clinical trial, called the Immune Biomarker Study for Head and Neck Cancer, is focused on understanding how the immune system responds to newly diagnosed head and neck cancers. Researchers want to find out if certain immune markers in both the tumor and the blood can help predict how well patients will respond to treatment. By looking at these markers, they aim to create a score that can help doctors assess a patient's prognosis, which is essentially how likely they are to do well after treatment.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma in areas such as the oral cavity or throat, specifically in stages II to IVB. Participants will need to agree to provide samples of blood, saliva, and stool for the study. Those who have other types of cancer or certain health issues may not be eligible. If you join the study, you can expect to contribute to important research that could help improve future treatments for head and neck cancer patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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
  • Present drug abuse
  • 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

About University Of Erlangen Nürnberg Medical School

The University of Erlangen-Nürnberg Medical School is a prestigious institution dedicated to advancing medical research and improving healthcare outcomes through innovative clinical trials. Renowned for its interdisciplinary approach, the medical school fosters collaboration among experts in various fields, enabling the development of cutting-edge therapies and treatment protocols. With a commitment to ethical standards and patient safety, the institution actively contributes to the global medical community by conducting rigorous clinical studies aimed at enhancing the understanding and management of diverse health conditions.

Locations

Erlangen, Bavaria, Germany

Erlangen, Bavaria, Germany

Erlangen, Bavaria, Germany

Patients applied

0 patients applied

Trial Officials

Antoniu-Oreste Gostian, PD Dr. med.

Study Director

ENT - Head and Neck Surgery Department, University of Erlangen-Nurnberg

Markus Hecht, PD Dr. med.

Study Director

Radiation Oncology, University of Erlangen-Nurnberg

Manuel Weber, PD Dr. med. Dr. med. dent.

Principal Investigator

Maxillo-facial-surgery, University of Erlangen-Nurnberg

Udo Gaipl, Prof. Dr. rer. nat. habil.

Principal Investigator

Translational Radiobiology, University of Erlangen-Nurnberg

Benjamin Frey, PD Dr.-Ing. Dr. habil. med.

Principal Investigator

Translational Radiobiology, University of Erlangen-Nurnberg

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials