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

NCT ID: NCT07131566

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2036-03-31

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.

Detailed Description

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%.

Conditions

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Sentinel Node detection and Biopsy

Fine Needle aspiration from sentinel Lymph Nodes

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lars Olaf Cardell

OTHER

Sponsor Role: lead

Responsible Party

Lars Olaf Cardell

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Lars Olaf Cardell, Professor

Role: CONTACT

lars-olaf.cardell@ki.se

+46 8 123 800 00

Facility Contacts

Lars Olaf Cardell, Professor

Role: primary

lars-olaf.cardell@ki.se

+46 8 123 80 000

Other Identifiers

K 2022-2823

Identifier Type: OTHER

Identifier Source: secondary_id

Vetenskapsrådet 2024-03236

Identifier Type: -

Identifier Source: org_study_id