NCT05941676

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

July 3, 2023

Last Update Submit

July 3, 2023

Conditions

Head and Neck CancerSquamous Cell Carcinoma

Keywords

immune biomarkerstumor-infiltrating lymphocytesPD-L1 (programmed death ligand-1) expressionprognosishead and neck cancerhead and neck squamous cell carcinoma (HNSCC)radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    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.

    24 months

Secondary Outcomes (4)

  • Disease-specific survival (DSS)

    24 months

  • Disease-free survival (DFS)

    24 months

  • Locoregional-free survival (LRFS)

    24 months

  • Distant metastatic-free survival (DMFS)

    24 months

Study Arms (1)

Head and neck carcinoma patients

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

Diagnostic Test: Tumour immunoprofile evaluation

Interventions

Tumour immunoprofile evaluationDIAGNOSTIC_TEST

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

Head and neck carcinoma patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stage I-IVb HNSCC indicated for radical treatment - radiotherapy or radiochemotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (2)

  • 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.

    PMID: 37000447RESULT

  • 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.

    PMID: 38638854DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy specimen from the primary tumour in head and neck, before curative radiotherapy/radiochemotherapy

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous CellSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 12, 2023

Study Start

June 1, 2020

Primary Completion

August 30, 2022

Study Completion

June 30, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations

CZ(1)