Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)NCT07131566
Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer
An observational study of Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), run by Lars Olaf Cardell at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
- What is being tested?
- Sentinel Node detection and Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2025to Mar 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with HNSCC with surgery at Karolinska University Hospital, Stockholm Sweden
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Stockholm County, 17176
Lars Olaf Cardell, Professor, +46 8 123 80 000, lars-olaf.cardell@ki.se
About this study
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.
Read more
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.
Read the 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%.
- Being tested
- Sentinel Node detection and Biopsy
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Node detection and BiopsyProcedure or surgery
Fine Needle aspiration from sentinel Lymph Nodes
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline (at surgery or biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jun 2025
- Primary completionMar 2031 (estimated)
- Study completionMar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Olaf Cardell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Olaf Cardell, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131566
- Sponsor's protocol ID
- Vetenskapsrådet 2024-03236
- Other IDs
- K 2022-2823
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07131566
- Acronym / sponsor ID
- Vetenskapsrådet 2024-03236
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lars Olaf CardellUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2036 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with HNSCC with surgery at Karolinska University Hospital, Stockholm Sweden
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Node detection and BiopsyFine Needle aspiration from sentinel Lymph Nodes | Procedure or surgery | – |
Primary outcome
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
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
1 secondary outcome
Differential gene expression between sentinel node and non tumour draining lymph node.
Time frame: Baseline (at surgery or biopsy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
Active, not recruitingPhase 1
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Advanced Cancer, Advanced Malignancies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), run by Lars Olaf Cardell at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Olaf Cardell, Professor (+46 8 123 800 00, lars-olaf.cardell@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cervical lymph nodes with tumor cells detected by flow cytometry (time frame: Baseline (at surgery or biopsy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.