HNSCC Immuno-genomics Project

NCT ID: NCT06725342

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 401 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-19
• Study Completion Date: 2024-03-01

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

Conditions

Molecular Classification of HNSCC

Keywords

head and neck cancer; genomics; immune-related gene expression

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Combined DNA/RNA sequencing on clinical FFPE material (technically challenging; innovative); immuno-genomics test.

Dual extractions (DNA/RNA) will be carried out from macrodissected thick unstained FFPE sections; samples will be measured for adequate quality / quantity; libraries will be constructed separately with each panel and samples will be sequenced in the same chip in an Ion Torrent Proton System, according to the manufacturer's instructions.

Sequencing results will be called with the Variant Caller for each panel and submitted for initial analysis and annotation to the Ion Reporter pipeline with each DNA and RNA panel

Intervention Type: GENETIC

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ΗΕ5R/18

Identifier Type: -

Identifier Source: org_study_id