Clinical trial NCT06725342: HNSCC Immuno-genomics Project
Official title: Immune Response Dynamics Predicted by Genomic Patterns in Head and Neck Cancer (HNSCC): a Translational Research Study of the Hellenic Cooperative Oncology Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molecular Classification of HNSCC
Keywords: head and neck cancer
genomics
immune-related gene expression
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced squamous cell carcinoma of the head and neck who were treated with concurrent chemoradiotherapy (CCRT) with or without induction chemotherapy (IC) or radical surgery +/- radiotherapy for laryngeal tumors.

Brief summary: For locally advanced and recurrent / metastatic head \& neck squamous cell carcinoma (HNSCC), the is an unmet need for the development of efficient treatment combinations, particularly with immune checkpoint inhibitors. HNSCC have been characterized at the genetic / molecular level concerning characteristics of malignancy and potential clinical actionability ; currently, however, the integration of molecular characteristics of both the malignant cells and the host immune response are considered fundamental for the selection of treatment that best suits these patients .

The primary objective of the NCR-17-12885 project is to classify HNSCC for the selection of optimal therapeutic interventions for the patients, based on genomic characteristics and mutational processes operating in these tumours and on the prevailing activated immune pathways.

Detailed description: Herein we propose the development of a combined genomic and gene expression assay for the comprehensive evaluation of HNSCC for the classification of tumors into (a) those with activated checkpoint molecules and activated T cells, likely to respond to checkpoint inhibition in the case of non-operable disease or recurrent disease without prior treatment; (b) those with inducible checkpoint and T cell response prior to the administration of checkpoint inhibitors; (c) those with activated early inflammatory response that needs to be transformed to cell mediated activation; and (d) those with stable genomes and no immune activation probably necessitating induction of genomic instability and T cell activation.

The test to be developed will provide information on the genomic integrity of the tumor and on a global immune related gene expression profile, both by next generation sequencing

Eligibility criteria: Inclusion Criteria:

-Patients with locally advanced squamous cell carcinoma of the head and neck who were treated with concurrent chemoradiotherapy (CCRT) with or without induction chemotherapy (IC) or radical surgery +/- radiotherapy for laryngeal tumors.

Exclusion Criteria:

* Age \<18 years old
* Non-squamous cell carcinomas of the head and neck.

Primary outcomes:
measure: Classification of HNSCC based on their genomic and immune-related gene expression characteristics.
timeFrame: 5 years
Secondary outcomes:
measure: Report on analytical performance of the test
timeFrame: 5 years
measure: HNSCC classification for comparison with (a) PD-L1 IHC (SP263 assay), and (b) the combined IFNG/PD-L1 mRNA ratio (qRT-PCR)
timeFrame: 5 years
measure: Provision of genomic markers predicting for immune status classes
timeFrame: 10 years
measure: One step "immuno-genomics test"
timeFrame: 10 years
measure: Reclassification of HNSCC with the "immuno-genomics test"
timeFrame: 10 years
measure: Publication of the results
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References: