Prognostic Immune Biomarkers in HNSCC

Sponsor

University Hospital Ostrava (Other)

Overall Status

Completed

CT.gov ID

NCT05941676

Collaborator

(none)

Enrollment

Location

36.9

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of the prognostic potential of tumor-infiltrating lymphocytes and PD-L1 expression in non-metastatic squamous cell carcinoma of the head and neck

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Squamous Cell Carcinoma	Diagnostic Test: Tumour immunoprofile evaluation

Detailed Description

The role of the immune system in the process of tumor growth and progression in head and neck (HaN) cancer has become of increasing importance. In the last years, the concept of tumor immune microenvironment (TIME) with the presence of tumor cells (TC) and infiltrating immune cells (IC) has been intensively studied. The results of available clinical studies suggest a positive impact of tumor-infiltrating lymphocytes (TILs) on the prognosis of HNSCC patients and their overall (OS) and cancer specific survivals. Beside TILs, an integral component of TIME is the immunosuppressive activity represented by inhibitory signalling molecules expressed on tumor cells (TCs) and immune cells (ICs).

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.

Study Design

Study Type:

Observational

Actual Enrollment :

55 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of the Prognostic Potential of New Immune Biomarkers in Non-metastatic Squamous Cell Carcinoma of the Head and Neck

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Aug 30, 2022

Actual Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Head and neck carcinoma patients Head and neck carcinoma patients will be enrolled in this study group.	Diagnostic Test: Tumour immunoprofile evaluation Tumour immunoprofile evaluation will be performed in patients with head and neck cancer.

Arm

Intervention/Treatment

Head and neck carcinoma patients

Head and neck carcinoma patients will be enrolled in this study group.

Diagnostic Test: Tumour immunoprofile evaluation

Tumour immunoprofile evaluation will be performed in patients with head and neck cancer.

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [24 months]
Overall survival measured in months - calculated from the date of initiation of radiotherapy to the date of death from any cause or the date of the last follow-up visit.

Secondary Outcome Measures

Disease-specific survival (DSS) [24 months]
Disease-specific survival calculated from the date of initiation of radiotherapy to the date of cancer death, or date of the last follow-up visit. Patients who died from causes other than HNSCC are censored at the time of death.
Disease-free survival (DFS) [24 months]
Disease-free survival calculated from the date of initiation of radiotherapy to the date of detection of any recurrence, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence are censored at the last follow-up contact.
Locoregional-free survival (LRFS) [24 months]
Locoregional-free survival calculated from the date of initiation of radiotherapy to the date of detection of clinical, radiological and/or pathological evidence of recurrence or tumor progression at the primary site or in the regional nodal area, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence are censored at the last follow-up contact.
Distant metastatic-free survival (DMFS) [24 months]
Distant metastatic-free survival calculated from the date of initiation of radiotherapy to the date of detection of distant metastasis of the tumor, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence were censored at the last follow-up contact.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients with non-metastatic squamous-cell head and neck cancer (HNSCC) stage I-IVb indicated for curative/radical treatment
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:

Histological type other than squamous cell carcinoma
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.