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NCT Number: NCT07131566

Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer

Objective:

The aim of this study is to characterize the inflammatory response in patients with head and neck cancer. More specifically, the study intend to investigate inflammatory and genetic differences between the primary tumor, the sentinel lymph node, and other regional lymph nodes. The investigator also aim to assess how the immunological and genetic responses differ in lymph nodes with and without metastases.

To enable the detection of metastases in lymph nodes containing very few cancer cells, the investigator are developing a method to identify tumor cells using flow cytometry. Additionally, both tumor tissue and lymph nodes will undergo in vitro testing of checkpoint blockade therapy, a relatively new form of cancer immunotherapy.

Methods:

Biopsies from the primary tumor will be used to assess local inflammation. Fine-needle aspirates and dissected lymph node tissue will be analyzed to study inflammatory and genetic responses, as well as to detect tumor cells within these nodes. Blood samples from patients with head and neck cancer will be analyzed for inflammatory mediators.

Lymph nodes from patients without cancer will be collected during benign neck surgeries. Immunological and genetic parameters from these control lymph nodes will be compared to those from the cancer patients to identify disease-specific patterns.

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Key information

Conditions

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

Location status: Recruiting

Location contact

Lars Olaf Cardell, Professor

CONTACT

[email protected]

+46 8 123 80 000

About this study

Statistical analyse Plan: All data will be log-transformed to approximate normal distribution. For pairwise comparisons Student's t-test will be used. For multiple comparisons one-way ANOVA followed by a suitable post-hoc test will be performed.

Power: Power has been determined based on available previous data. The investigator will have access to samples from up to 300 study subjects that can be used generate different datasets. The calculated sample size ranges from 20 to 60 samples per group depending on the specific research question. This calculation was conducted assuming two-tailed comparisons, with, significance p<0.05, and power 80%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a diagnosis of primary HNSCC,
  • tumor excision combined with a sentinel node-assisted elective neck dissection or sentinel node biopsy alone performed at Karolinska University Hospital, Stockholm, Sweden
  • willingness to participate in the study.

Exclusion criteria

  • systematic autoimmune diseases
  • synchronous or previous second malignancies or hemo-lymphopoietic malignancies
  • any other acute or chronic condition that could influence the immunological environment in the lymph nodes.

Treatment and study plan

Sentinel Node detection and Biopsy

Procedure

Fine Needle aspiration from sentinel Lymph Nodes

Primary outcomes

  1. Proportion of cervical lymph nodes with tumor cells detected by flow cytometry

    Time frame: Baseline (at surgery or biopsy)

    Flow cytometric detection of tumor cells in sentinel node, other cervical lymph nodes, or fine-needle aspirates. Reported as the percentage of examined lymph nodes containing tumor cells. Unit of measure: % of lymph nodes

  2. Immunological cell profile in sentinel node measured by flow cytometry

    Time frame: Baseline (at surgery or biopsy)

    Quantification of immune cell populations (e.g., CD4+, CD8+ T cells, B cells) in sentinel node, expressed as number of cells per mg of tissue. Unit of measure: % of total cells

Secondary outcomes

  1. Differential gene expression between sentinel node and non tumour draining lymph node.

    Time frame: Baseline (at surgery or biopsy)

    RNA sequencing of biopsies from sentinel node and non tumour draining lymph node to identify differentially expressed genes (log2 fold change, p-value).unit of measure: Fold change in gene expression

Other outcomes

  1. Topographical localization of sentinel node

    Time frame: Baseline (pre-surgery imaging)

    SPECT-CT imaging to determine sentinel node location, reported as frequency (%) of nodes located in predefined anatomical regions. Unit of measure: % of sentinel nodes in each location

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Olaf Cardell, Professor

CONTACT

[email protected]

+46 8 123 800 00

Sponsors and collaborators

Lead sponsor

Lars Olaf Cardell

Other

Registry information

Important dates

Study start
2025
Primary completion
2031
Study completion
2036
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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