Study of immune biomarkers in head and neck cancer
Immune Biomarker Study for Head and Neck Cancer
This study is testing if certain immune markers in patients with newly diagnosed head and neck cancer can help predict their treatment outcomes and guide their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 3 sites (Erlangen, Bavaria and 2 other locations) |
| Trial ID | NCT05375266 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prognostic value of immune biomarkers in patients with newly diagnosed non-metastatic head and neck cancer. It will analyze both intratumoral and systemic immune responses, correlating local tumor immunology with systemic immune status through blood samples. Additionally, tumor organoids will be created for further biological analysis, with the goal of developing a prognostic score based on immune characteristics. The study focuses on understanding how these immune markers can inform treatment decisions and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with an initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses, or larynx at stages UICC II-IVB.
Not a fit: Patients with distant metastases or simultaneous secondary carcinomas at the time of diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic assessments and personalized treatment strategies for patients with head and neck cancer.
How similar studies have performed: While the study's approach is novel in its comprehensive analysis of immune markers in this specific cancer type, similar studies have shown promise in other cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Erlangen, Bavaria and 2 other locations
- ENT - Head and Neck Surgery Department — Erlangen, Bavaria, Germany (Recruiting)
- Maxillo-Facial-Surgery Department — Erlangen, Bavaria, Germany (Recruiting)
- Radiation Oncology Department — Erlangen, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Manuel Weber, PD Dr. med. Dr. med. dent. — Maxillo-facial-surgery, University of Erlangen-Nurnberg
- Study coordinator: Antoniu-Oreste Gostian, PD Dr. med.
- Email: antoniu-oreste.gostian@uk-erlangen.de
- Phone: +49 9131 85-33156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.