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RecruitingNCT05375266

Immune Biomarker Study for Head and Neck Cancer

Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

1,100 participants

Start Date

May 16, 2022

Study Type

OBSERVATIONAL

Conditions

Head and Neck CancerHypopharyngeal CancerLaryngeal CancerOral Cavity CancerOropharyngeal Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how the immune system responds to head and neck cancers by analyzing blood, saliva, and stool samples. The goal is to find biological markers that could help predict how patients respond to treatment. **You may be eligible if...** - You have been newly diagnosed with squamous cell carcinoma of the mouth, throat, voice box, or nasal sinuses (Stage II–IVB) - You are 18 years or older - You are mentally able to understand the study and give consent - You are willing to provide blood, saliva, and stool samples - OR you are a healthy patient having ear, nose, or jaw surgery (as a comparison group) **You may NOT be eligible if...** - You have cancer that has spread to distant organs - You have a second cancer at the same time - You are in the healthy comparison group but have a history of any cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSampling

This is an observational study. Consequently, study participation does not alter the therapy of the treated disease. Blood will be drawn from patients at several time points during and after radiotherapy (RT) and therapy with immune checkpoint inhibitor (ICI) for detailed immunomonitoring of the patients. In addition, faeces and sputum of the patients for microbiomic and metabolomic measures will be collected. Whenever possible, adequate tissue samples are taken from the center of the tumor and a biopsy is taken from the edge of the tumor including the adjacent mucosa in the nearby area without affecting the pathological assessment (study group). Blood, faeces and sputum will be taken from patients of the control group prior to surgery. After surgery, only blood will be taken.

Locations(3)

ENT - Head and Neck Surgery Department

Erlangen, Bavaria, Germany

Maxillo-Facial-Surgery Department

Erlangen, Bavaria, Germany

Radiation Oncology Department

Erlangen, Bavaria, Germany

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NCT05375266

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