NCT05375266 Immune Biomarker Study for Head and Neck Cancer
| NCT ID | NCT05375266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Head and Neck Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2022-05-16 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,100 participants in total. It began in 2022-05-16 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 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
Contact & Investigator
Antoniu-Oreste Gostian, PD Dr. med.
STUDY DIRECTOR
ENT - Head and Neck Surgery Department, University of Erlangen-Nurnberg
Frequently Asked Questions
Who can join the NCT05375266 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05375266 currently recruiting?
Yes, NCT05375266 is actively recruiting participants. Contact the research team at antoniu-oreste.gostian@uk-erlangen.de for enrollment information.
Where is the NCT05375266 trial being conducted?
This trial is being conducted at Erlangen, Germany, Erlangen, Germany, Erlangen, Germany.
Who is sponsoring the NCT05375266 clinical trial?
NCT05375266 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Antoniu-Oreste Gostian, PD Dr. med. at ENT - Head and Neck Surgery Department, University of Erlangen-Nurnberg. The trial plans to enroll 1,100 participants.
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