Status:
RECRUITING
Immune Biomarker Study for Head and Neck Cancer
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborating Sponsors:
University Hospital Erlangen
University Hospital Regensburg
Conditions:
Head and Neck Cancer
Oral Cavity Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
Except for human papillomavirus(HPV)-associated oropharyngeal cancer, immunological biomarkers do not influence treatment algorithms in locally advanced head and neck cancer. In the meantime, a progno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT05375266
Start Date
May 16 2022
End Date
March 31 2027
Last Update
May 17 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
ENT - Head and Neck Surgery Department
Erlangen, Bavaria, Germany, 91054
2
Maxillo-Facial-Surgery Department
Erlangen, Bavaria, Germany, 91054
3
Radiation Oncology Department
Erlangen, Bavaria, Germany, 91054