Actively Recruiting
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
Eligibility Criteria
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
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
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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