Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2020-06-01
2023-06-30
Brief Summary
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Detailed Description
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One of these molecules is programmed death-ligand 1 (PD-L1), which inhibits the cytotoxic immune response mediated by T-lymphocytes.
The aim of this observational cohort study is to assess the prognostic potential of novel immune biomarkers in patients with HNSCC tumors stage I-IVb treated with radical radiotherapy and radiochemotherapy. Specifically, the association between high and low TILs infiltration and OS and cancer specific survival parameters will be investigated. As well as the association between high and low PD-L1 expression and OS and cancer specific survival parameters will be investigated.
This is a non-interventional study conducted in one institution - Department of oncology, University hospital Ostrava. The tumor immunoprofile defined by the presence of immune biomarkers (TIL, PD-L1) will be evaluated in each patient from biopsy specimens in representative hematoxylin and eosin stained sections by immuno-histochemistry. The Cox proportional risk model will be used to estimate the prognostic potential of each of the biomarker.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Head and neck carcinoma patients
Head and neck carcinoma patients will be enrolled in this study group.
Tumour immunoprofile evaluation
Tumour immunoprofile evaluation will be performed in patients with head and neck cancer.
Interventions
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Tumour immunoprofile evaluation
Tumour immunoprofile evaluation will be performed in patients with head and neck cancer.
Eligibility Criteria
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Inclusion Criteria
* Histologically verified squamous cell carcinoma including HPV-positive carcinomas
* Tumor site: oropharynx, larynx, hypopharynx, oral cavity, nasal cavity
* Treatment modality - radiotherapy or radiochemotherapy
* Presence of immune biomarkers in the tissue - tumor-infiltrating lymphocytes (TILs) and/or PD-L1 expression
* Sufficient data on patient follow-up
Exclusion Criteria
* Paranasal sinus tumors, thyroid and nasopharyngeal carcinomas, salivary gland tumors, mucosal melanoma, skin carcinoma, lymphomas, and occult primary tumors
* Synchronous malignancies or recurrent disease
* The previous use of radiotherapy
* The presence of distant metastatic disease
* Missing or inadequate follow-up data
* The inability to evaluate biomarkers (TILs or PD-L1) in a histological tissue sample.
18 Years
90 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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References
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Blazek T, Petras M, Knybel L, Cvek J, Soumarova R. Programmed Cell Death Ligand 1 Expression on Immune Cells and Survival in Patients With Nonmetastatic Head and Neck Cancer: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 Mar 1;6(3):e236324. doi: 10.1001/jamanetworkopen.2023.6324.
Blazek T, Petras M, Hurnik P, Matousek P, Knybel L, Cermakova ZZ, Stembirek J, Cvek J, Soumarova R. High PD-L1 expression on immune cells along with increased density of tumor-infiltrating lymphocytes predicts a favorable survival outcome for patients with loco-regionally advanced head and neck cancer: early results from a prospective study. Front Oncol. 2024 Apr 4;14:1346793. doi: 10.3389/fonc.2024.1346793. eCollection 2024.
Other Identifiers
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RVO-FNOs/2021
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ONKOL-01-Head and neck
Identifier Type: -
Identifier Source: org_study_id
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