Actively Recruiting

Age: 18Years +
All Genders
NCT05375266

Immune Biomarker Study for Head and Neck Cancer

Led by University of Erlangen-Nürnberg Medical School · Updated on 2023-05-17

1100

Participants Needed

3

Research Sites

254 weeks

Total Duration

On this page

Sponsors

U

University of Erlangen-Nürnberg Medical School

Lead Sponsor

U

University Hospital Erlangen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Immune Biomarker Study for Head and Neck Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses, or larynx in stage UICC II-IVB (study group)
  • Patients with diseases other than malignant diseases who require ear, nose, or maxillofacial surgery (control group)
  • No current or previous malignant disease regardless of location (control group)
  • Agreement to provide blood, saliva, and stool samples and consent to store samples for future research
  • Age 18 years or older
  • Ability to understand and consent to the study
Not Eligible

You will not qualify if you...

  • Presence of distant metastases or simultaneous secondary carcinoma at diagnosis
  • Tumors where sampling would interfere with pathological assessment
  • Current drug abuse
  • Inability or unwillingness to follow study protocol
  • Legal guardianship status
  • Language barriers preventing study participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

ENT - Head and Neck Surgery Department

Erlangen, Bavaria, Germany, 91054

Actively Recruiting

2

Maxillo-Facial-Surgery Department

Erlangen, Bavaria, Germany, 91054

Actively Recruiting

3

Radiation Oncology Department

Erlangen, Bavaria, Germany, 91054

Actively Recruiting

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Research Team

A

Antoniu-Oreste Gostian, PD Dr. med.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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