NCT05375266Recruiting
Immune Biomarker Study for Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 17 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1100 (estimated)
- First submitted
- 29 Mar 2022
- Start date
- May 2022
- Primary completion date
- Mar 2026
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Head and neck cancer
- NCT number
- NCT05375266
What you commit to
- Study type: Observational
- Planned participants: 1100
- From May 2022 to the primary completion date, Mar 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Present drug abuse
Other
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maxillo-Facial-Surgery Department Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| ENT - Head and Neck Surgery Department Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Radiation Oncology Department Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.