Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2026-01-25 @ 1:03 AM
Study NCT ID:
NCT07131566
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2036-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Topographical localization of sentinel node', 'timeFrame': 'Baseline (pre-surgery imaging)', 'description': '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'}], 'primaryOutcomes': [{'measure': 'Proportion of cervical lymph nodes with tumor cells detected by flow cytometry', 'timeFrame': 'Baseline (at surgery or biopsy)', 'description': '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'}, {'measure': 'Immunological cell profile in sentinel node measured by flow cytometry', 'timeFrame': 'Baseline (at surgery or biopsy)', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Differential gene expression between sentinel node and non tumour draining lymph node.', 'timeFrame': 'Baseline (at surgery or biopsy)', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)']}, 'descriptionModule': {'briefSummary': 'Objective:\n\nThe 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.\n\nTo 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.\n\nMethods:\n\nBiopsies 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.\n\nLymph 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.', 'detailedDescription': "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.\n\nPower: 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%."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with HNSCC with surgery at Karolinska University Hospital, Stockholm Sweden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. a diagnosis of primary HNSCC,\n2. tumor excision combined with a sentinel node-assisted elective neck dissection or sentinel node biopsy alone performed at Karolinska University Hospital, Stockholm, Sweden\n3. willingness to participate in the study.\n\nExclusion Criteria:\n\n1. systematic autoimmune diseases\n2. synchronous or previous second malignancies or hemo-lymphopoietic malignancies\n3. any other acute or chronic condition that could influence the immunological environment in the lymph nodes.'}, 'identificationModule': {'nctId': 'NCT07131566', 'briefTitle': 'Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'Vetenskapsrådet 2024-03236'}, 'secondaryIdInfos': [{'id': 'K 2022-2823', 'type': 'OTHER', 'domain': 'Karolinska Sjukhuset'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sentinel Node detection and Biopsy', 'type': 'PROCEDURE', 'description': 'Fine Needle aspiration from sentinel Lymph Nodes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Lars Olaf Cardell, Professor', 'role': 'CONTACT', 'email': 'lars-olaf.cardell@ki.se', 'phone': '+46 8 123 80 000'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Lars Olaf Cardell, Professor', 'role': 'CONTACT', 'email': 'lars-olaf.cardell@ki.se', 'phone': '+46 8 123 800 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Olaf Cardell', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lars Olaf Cardell', 'investigatorAffiliation': 'Karolinska Institutet'}}}}