Head and Neck Cancer Clinical Trial
— ImmunBio-KHTOfficial title:
Immune Biomarker Study for Head and Neck Cancer
NCT number | NCT05375266 |
Other study ID # | 12-384-B |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 16, 2022 |
Est. completion date | March 31, 2027 |
The aim of this prospective non-interventional multi-center trial is to study the prognostic value of intratumoral and systemic immune biomarkers in newly diagnosed non-metastatic head and neck cancer. Furthermore, the local immunological processes in the tumor will be correlated with the systemic immune status determined in the peripheral blood to identify prognostic immune signatures. In addition, tumor organoids will be generated ex vivo for functional biological analyses. The main objective is to create a prognostic score determined by clusters based on tumor immunologic criteria.
Status | Recruiting |
Enrollment | 1100 |
Est. completion date | March 31, 2027 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC II-IVB (study group) - Diseases other than malignant diseases (patients with the indication for surgery of the ear, nose nose or maxillofacial surgery) (control group) - Absence of a currently existing or previous malignant disease regardless of the anatomical localization (control group) - Agreement of the patients for sampling blood, saliva and stool as well as consent to the preservation of all samples for further study purposes - Age = 18 years - Cognitive ability of the patients to understand the meaning and purpose of the study and agree to it Exclusion Criteria: - Distant metastases and / or simultaneous secondary carcinoma at the time of diagnosis (= inclusion date) - Carcinomas in which it is (likely) impossible to take a sample without interfering with the further pathological assessment - Present drug abuse - Patients who are unable or unwilling to behave and receive treatment according to protocol - Patients who are legally patronized - Patients who are not eligible for participation in the study due to language barrier |
Country | Name | City | State |
---|---|---|---|
Germany | ENT - Head and Neck Surgery Department | Erlangen | Bavaria |
Germany | Maxillo-Facial-Surgery Department | Erlangen | Bavaria |
Germany | Radiation Oncology Department | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School | University Hospital Augsburg, University Hospital Erlangen, University Hospital Regensburg |
Germany,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Observation of changes in an established immune matrix (intratumoral and systemic) of responding/non-responding patients at certain points in time in the course of treatment | Based on the intrinsic immunological biology of the tumors, different immune cells and tumor cell markers will characterize immunological groups using cluster analysis.
Immune matrix of patients assessed by LIPS (liquid immune profile-based signature) (acc. Zhou et al. JITC 2021) and Tumour Associated Lymphocytes (TAL). |
Change of the immune matrix from baseline (before surgery; day0) and after surgery (day 7) and at the end of radiotherapy (day 60-70) and end of study period up to 5 years | |
Secondary | Longitudinal immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during study period | The distribution of immune cells and messenger substances in the blood will be examined by means of immunophenotyping in order to add the systemic immune cell composition.
Flow cytometric assessment of the amount of circulating immune cell-distribution per milliliter whole blood according to the LIPS (liquid immune profile-based signature) technique (Zhou et al. JITC 2021). |
The analyses are conducted at time points before (day 0) surgery and after surgery (day 7) as well as at the end of radiotherapy (day 70-80) or end of study period up to 5 years | |
Secondary | Analysis of cytokines in peripheral blood and their change at certain points in the course of treatment | Electrochemiluminescent MULTI-ARRAY measurement of concentration (pg/ml whole blood) cytokines/chemoattractant cytokines in the serum/plasma of the patients according to the LIPS (liquid immune profile-based signature) technique (Zhou et al. JITC 2021). | The analyses are conducted at time points before (day 0) surgery and after surgery (day 7) as well as at the end of radiotherapy (day 70-80) or end of study period up to 5 years | |
Secondary | Determination of transcription processes in the immune cells at certain points in the course of treatment to extend the prognostic immune signature | Genetic profiling (Whole exome sequencing, RNASeq, ddPCR, realtimePCR) of transcribed genes in blood lymphocytes. | The analyses are conducted at time points before (day 0) surgery and after Surgery (day 7) as well as at the end of radiotherapy (day 70-80) or end of study period up to 5 years | |
Secondary | Analysis of patient's metabolic state | Massspectometric untargeted metabolomic of patients serum/plasma to assess the change of metabolites (pg/ml whole blood) from baseline to end of radiotherapy. | The analyses are conducted at time points before (day 0) surgery and after Surgery (day 7) as well as at the end of radiotherapy (day 70-80) or end of study period up to 5 years | |
Secondary | Analysis of patient's microbiomic state by examination of saliva, tumor and stool | 16S rRNA deep sequencing of microbiome in salvia, tumour and stool samples to assess the presence and relative distribution of microbiotes (Operational taxonomic units [OTUs]). | The analyses are conducted at time point before surgery (day 0) |
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