Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLars Olaf Cardell
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients diagnosed with HNSCC with surgery at Karolinska University Hospital, Stockholm Sweden
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Sentinel Node detection and Biopsy
Procedure/SurgeryFine Needle aspiration from sentinel Lymph Nodes
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline (at surgery or biopsy)2
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
Time frame
Baseline (at surgery or biopsy)Secondary outcomes
1
Differential gene expression between sentinel node and non tumour draining lymph node.
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
Time frame
Baseline (at surgery or biopsy)Other outcomes
1
Topographical localization of sentinel node
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
Time frame
Baseline (pre-surgery imaging)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lars Olaf Cardell
Lead sponsor
Karolinska Institutet
Sponsor institution
Source ClinicalTrials.gov