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Characterizing the Tumor Immune Microenvironment of Head and Neck Squamous Cell Carcinoma

Characterizing the Tumor Immune Microenvironment of Head and Neck Squamous Cell Carcinoma - HNcol 2.0

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56910
Enrollment
1600
Registered
2024-07-12
Start date
2025-04-03
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer head and neck squamous cell carcinoma

Interventions

None listed

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Too limited size of the carcinoma according to the treating physician.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to define the TiME in the various anatomical and molecular HNSCC subclasses (HPV-related, non-HPV related CNA-other and non-HPV related CNA-quiet) and to comprehend which molecular and/or immune mechanisms relate with prognosis and response to therapies. Differences in the TiME will be assessed by flow cytometry, multiplexed immunohistochemistry, DNA/RNA sequencing, spatial transcriptomics, primary tumor cultures and functional immune assays.

Secondary

MeasureTime frame
Secondary endpoints in our study will be TiME characteristics which are related to: 1. Immunotherapy response 2. Clinical outcome / overall survival 3. New immune suppressive mechanisms in HNSCC

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)