HNSCC Immuno-genomics Project

NCT06725342 | Completed

• 1 other identifier: ΗΕ5R/18
• Study Type: observational
• Target: 401
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Molecular Classification of HNSCC

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Classification of HNSCC based on their genomic and immune-related gene expression characteristics.

  To classify HNSCC for the selection of optimal therapeutic interventions for the patients; classification will be based on present genomic characteristics and mutational processes behind them, and on the prevailing activated immune pathways.

  5 years

Secondary Outcomes (6)

• Report on analytical performance of the test

  5 years

• HNSCC classification for comparison with (a) PD-L1 IHC (SP263 assay), and (b) the combined IFNG/PD-L1 mRNA ratio (qRT-PCR)

  5 years

• Provision of genomic markers predicting for immune status classes

  10 years

• One step "immuno-genomics test"

  10 years

• Reclassification of HNSCC with the "immuno-genomics test"

  10 years

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Biospecimen

Retention: SAMPLES WITH DNA

FFPE tissue blocks

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 10, 2024
• Study Start: December 19, 2014
• Primary Completion: July 1, 2019
• Study Completion: March 1, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12