Characterizing the Tumor Immune Microenvironment of Head and Neck Squamous Cell Carcinoma
- Conditions
- head and neck cancerhead and neck squamous cell carcinoma10027655
- Registration Number
- NL-OMON56910
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1600
1. Patients are scheduled for panendoscopy or surgery for squamous cell
carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or cervical part
of oesophagus.
2. Patients must have sufficient knowledge of the Dutch language to understand
the meaning of the study as described in the patient information.
3. Patients must have the mental capacity to understand the meaning of the
study as described in the patient information.
4. Patients must give written informed consent.
5. Age of the patients should be >18. An upper limit of age will not be
applied. Elderly patients who are fit enough to undergo surgery in the head and
neck area are not likely to encounter negative effects of the extra procedures
that will be applied as part of the study.
Too limited size of the carcinoma according to the treating physician.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to define the TiME in the various<br /><br>anatomical and molecular HNSCC subclasses (HPV-related, non-HPV related<br /><br>CNA-other and non-HPV related CNA-quiet) and to comprehend which molecular<br /><br>and/or immune mechanisms relate with prognosis and response to therapies.<br /><br>Differences in the TiME will be assessed by flow cytometry, multiplexed<br /><br>immunohistochemistry, DNA/RNA sequencing, spatial transcriptomics, primary<br /><br>tumor cultures and functional immune assays. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints in our study will be TiME characteristics which are related<br /><br>to:<br /><br>1. Immunotherapy response<br /><br>2. Clinical outcome / overall survival<br /><br>3. New immune suppressive mechanisms in HNSCC</p><br>