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Recruiting Observational

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

NCT07131566 · tracked via the Priya Life Science Sweden tracker
Sponsor
Lars Olaf Cardell
Phase
Observational
Started
2025-06-01
Last updated
2025-08-20

Condition(s) studied

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Investigational drug(s) / intervention(s)

Sentinel Node detection and Biopsy

Sentinel Node detection and Biopsy: Fine Needle aspiration from sentinel Lymph Nodes

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. a diagnosis of primary HNSCC, 2. tumor excision combined with a sentinel node-assisted elective neck dissection or sentinel node biopsy alone performed at Karolinska University Hospital, Stockholm, Sweden 3. willingness to participate in the study. Exclusion Criteria: 1. systematic autoimmune diseases 2. synchronous or previous second malignancies or hemo-lymphopoietic malignancies 3. any other acute or chronic condition that could influence the immunological environment in the lymph nodes.

Primary outcome measure(s)

  • Proportion of cervical lymph nodes with tumor cells detected by flow cytometry — 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
  • Immunological cell profile in sentinel node measured by flow cytometry — 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

Trial sites (1)

FacilityCityRegionStatus
Karolinska University Hospital Stockholm Stockholm County Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07131566 on ClinicalTrials.gov ↗ ← All trials in Sweden