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

NCT07131566 | Recruiting

• 2 other identifiers: Vetenskapsrådet 2024-03236K 2022-2823
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Outcome Measures

Primary Outcomes (2)

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

  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

  Baseline (at surgery or biopsy)

• Immunological cell profile in sentinel node measured by flow cytometry

  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

  Baseline (at surgery or biopsy)

Secondary Outcomes (1)

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

  Baseline (at surgery or biopsy)

Other Outcomes (1)

• Topographical localization of sentinel node

  Baseline (pre-surgery imaging)

Interventions

Sentinel Node detection and Biopsy PROCEDURE

Fine Needle aspiration from sentinel Lymph Nodes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with HNSCC with surgery at Karolinska University Hospital, Stockholm Sweden

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lars Olaf Cardell: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Lars Olaf Cardell, Professor

CONTACT

+46 8 123 800 00; lars-olaf.cardell@ki.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: August 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2036
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)