Immune Biomarker Study for Head and Neck Cancer

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
ENT - Head and Neck Surgery Department
RECRUITING
Erlangen
Maxillo-Facial-Surgery Department
RECRUITING
Erlangen
Radiation Oncology Department
RECRUITING
Erlangen
Contact Information
Primary
Antoniu-Oreste Gostian, PD Dr. med.
antoniu-oreste.gostian@uk-erlangen.de
+49 9131 85-33156
Time Frame
Start Date: 2022-05-16
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 1100
Treatments
Study Cohort
The study cohort consist of patients with newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC (Union internationale contre le cancer) II-IVB
Control Group
The control group consists of patients with no current diagnoses of cancer undergoing surgery at the participating medical center
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Regensburg, University Hospital Erlangen, University Hospital Augsburg
Leads: University of Erlangen-Nürnberg Medical School

This content was sourced from clinicaltrials.gov