Head and Neck CancerNCT05941676
Prognostic Immune Biomarkers in HNSCC
An observational study of Head and Neck Cancer and Squamous Cell Carcinoma, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Carcinoma
- What is being tested?
- Tumour immunoprofile evaluation
- How many people
- 55 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients with stage I-IVb HNSCC indicated for radical treatment - radiotherapy or radiochemotherapy
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: Evaluation of the Prognostic Potential of New Immune Biomarkers in Non-metastatic Squamous Cell Carcinoma of the Head and Neck
Evaluation of the prognostic potential of tumor-infiltrating lymphocytes and PD-L1 expression in non-metastatic squamous cell carcinoma of the head and neck
Read the 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.
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma
- Being tested
- Tumour immunoprofile evaluation
- Keywords
- immune biomarkers, tumor-infiltrating lymphocytes, PD-L1 (programmed death ligand-1) expression, prognosis, head and neck cancer, head and neck squamous cell carcinoma (HNSCC), radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumour immunoprofile evaluationDiagnostic test
Tumour immunoprofile evaluation will be performed in patients with head and neck cancer.
| Study group | Role | What they receive |
|---|---|---|
| Head and neck carcinoma patients | Head and neck carcinoma patients will be enrolled in this study group. Receives: Diagnostic Test: Tumour immunoprofile evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
Disease-specific survival (DSS)
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.
Measured: 24 months
Disease-free survival (DFS)
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.
Measured: 24 months
Locoregional-free survival (LRFS)
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.
Measured: 24 months
Distant metastatic-free survival (DMFS)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jun 2020
- Primary completion30 Aug 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941676
- Sponsor's protocol ID
- ONKOL-01-Head and neck
- Other IDs
- RVO-FNOs/2021
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
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.
PubMed 37000447Blazek 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.
PubMed 38638854
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Potential of New Immune Biomarkers in Non-metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT05941676
- Acronym / sponsor ID
- ONKOL-01-Head and neck
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma
- Keywords
- immune biomarkers, tumor-infiltrating lymphocytes, PD-L1 (programmed death ligand-1) expression, prognosis, head and neck cancer, head and neck squamous cell carcinoma (HNSCC), radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the prognostic potential of tumor-infiltrating lymphocytes and PD-L1 expression in non-metastatic squamous cell carcinoma of the head and neck
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck carcinoma patients | – | Diagnostic Test: Tumour immunoprofile evaluationHead and neck carcinoma patients will be enrolled in this study group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I-IVb HNSCC indicated for radical treatment - radiotherapy or radiochemotherapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumour immunoprofile evaluationTumour immunoprofile evaluation will be performed in patients with head and neck cancer. | Diagnostic test | Head and neck carcinoma patients |
Primary outcome
Overall survival (OS)
Time frame: 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.
4 secondary outcomes
Disease-specific survival (DSS)
Time frame: 24 months
Disease-free survival (DFS)
Time frame: 24 months
Locoregional-free survival (LRFS)
Time frame: 24 months
Distant metastatic-free survival (DMFS)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Results publication: PubMed 37000447Blazek 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.
- Derived from this study: PubMed 38638854Blazek 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Squamous Cell Carcinoma, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941676, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.