Immune Biomarker Study for Head and Neck Cancer (ImmunBio-KHT)

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Laryngeal Cancer; Oropharyngeal Cancer; Oral Cavity Cancer; Head and Neck Cancer; Hypopharyngeal Cancer

Treatments: Other: Sampling

Study type: Observational

Funder types: Other

Identifiers

NCT05375266

12-384-B

Details and patient eligibility

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.

Full 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 prognostic significance of tumor infiltrating lymphocytes has been recognized. However, these biomarkers do not influence clinical decisions. This may be due to previous focus on the entire group of heterogeneous squamous cell carcinomas in the head and neck region, while the tumor localization has been neglected. In addition, the isolated observation of singular immune cell populations may not be sufficient with regard to the complex interactions of the tumor with the local and systemic immune system, e.g. the presence of regulatory T cells (FoxP3+) in immunologically highly active tumors ("inflamed" or "hot") improves the prognosis, whereas the prognosis is worsened in immunologically less active tumors ("immune desert").The immune checkpoint molecule programmed death-ligand 1 (PD-L1) is currently used as a single predictive marker for immunotherapy with PD(L)-1 inhibitors. Certainly, combined prospective analyses of immune cells and immune checkpoint molecules in large patient cohorts are scarce so far. Of note, the prognostic relevance of immune cells and immunologically active substances in the peripheral blood serving as makers for immunotherapies has already been described. Yet prognostic and predictive markers in the peripheral blood have rarely been studied or linked to the local tumor immune status. However, analyses of single biomarkers of local and systemic immune responses and different immune cell populations can be expected to gain prognostic precision through cluster formation and allow grouping of head and neck tumors according to immunobiological criteria rather than anatomic localization. Therefore, the investigators expect to be able to identify an immunobiological biomarker signature for head and neck tumors that will contribute to the development of future individualized treatment approaches leading to precision head and neck oncology.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,100 participants in 2 patient groups

Study Cohort

Description:

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

Treatment:

Other: Sampling

Control Group

Description:

The control group consists of patients with no current diagnoses of cancer undergoing surgery at the participating medical center

Treatment:

Other: Sampling