Immune response in neck lymph nodes of people with head and neck cancer.
Official title: Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer
Run by Karolinska Institutet · NCT07131566 · Data updated 2026-11-12
This project will test whether immune and genetic differences between the primary tumor and nearby neck lymph nodes, including sentinel nodes, indicate whether cancer has spread in people with HNSCC.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Stockholm, Stockholm County) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | March 2031 |
| Study ends | March 2036 |
| Registry record updated | August 20, 2025 |
| Trial ID | NCT07131566 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are people with primary HNSCC undergoing tumor excision with sentinel node-assisted elective neck dissection or sentinel node biopsy at Karolinska University Hospital who are willing to join the study.
✕Probably not a fit
Patients with systemic autoimmune diseases, prior or synchronous second malignancies including hemo-lymphopoietic cancers, or other acute or chronic conditions that alter lymph node immunity would be excluded and are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will compare inflammation and genetic profiles in primary HNSCC tumors, sentinel lymph nodes, and other regional lymph nodes to identify differences between nodes with and without metastases. Samples include tumor biopsies, fine-needle aspirates, and dissected lymph node tissue collected during surgery at Karolinska University Hospital. Investigators will use flow cytometry to detect small numbers of tumor cells, perform genetic analyses, and carry out ex vivo testing of checkpoint blockade on tumor and lymph node samples. Statistical plans include log transformation of data, t-tests for pairwise comparisons, and one-way ANOVA with post-hoc testing, with sample sizes chosen to give approximately 80% power for the planned comparisons.
Why it matters
Potential benefit: If successful, the work could improve detection of tiny lymph node metastases and help guide personalized immunotherapy decisions for people with HNSCC.
How similar studies have gone: Related studies have used sentinel node analysis and flow cytometry to detect micro-metastases and performed ex vivo immune testing in other cancers, but combining these methods for detailed HNSCC lymph node characterization is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Karolinska University Hospital
Stockholm, Stockholm County, Sweden Recruiting
Study contacts
- Study coordinator: Lars Olaf Cardell, Professor
- Email: lars-olaf.cardell@ki.se
- Phone: +46 8 123 800 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.