Oral Squamous Cell Carcinoma (OSCC)IL6-OSCCNCT07692360
Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma
An observational study of Oral Squamous Cell Carcinoma (OSCC), run by University of Pavia at 2 sites in Italy.
Trial summary
This observational study will evaluate whether salivary interleukin-6 levels and selected interleukin gene polymorphisms are associated with regional lymph node involvement in patients with oral squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Saliva Collection and Biomarker Analysis
- Type of treatment
- Pill or oral medicine
- How many people
- 38 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients with histopathologically confirmed oral squamous cell carcinoma of the oral cavity, enrolled before any OSCC-specific oncological treatment. Participants will be classified according to regional lymph node status into two observational cohorts: OSCC N0M0, defined as absence of regional lymph node metastasis and absence of distant metastasis, and OSCC N+M0, defined as presence of regional lymph node metastasis and absence of distant metastasis. Patients will be recruited from participating Italian study centres involved in the clinical management of oral squamous cell carcinoma.
Who may be able to join
- Age 18 years or older
- Histopathologically confirmed diagnosis of oral squamous cell carcinoma of the oral cavity
- Oral squamous cell carcinoma site excluding oropharyngeal sites
- Defined regional lymph node status allowing classification as OSCC N0M0 or OSCC N+M0
- Absence of distant metastasis, classified as M0
- Saliva sample collection feasible before any OSCC-specific oncological treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy
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- Suitability for saliva collection using a standardized absorbent swab
- Availability of biological material for genotyping
- Ability to provide written informed consent for study participation, biological sampling, and genetic analysis
Who cannot join
- Age younger than 18 years
- Oral squamous cell carcinoma involving oropharyngeal sites
- Presence of distant metastasis
- Previous OSCC-specific oncological treatment before saliva sample collection
- Acute infection at the time of sampling or within the previous 2 weeks
- Active or inadequately controlled systemic autoimmune or inflammatory disease that may significantly alter cytokine profiles
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- Systemic immunosuppressive or immunomodulatory therapy within the previous 4 to 8 weeks
- Recent oncological treatment for malignancies other than OSCC within the previous 6 months, if considered potentially interfering with the immune-inflammatory profile
- Clinically significant acute oral infection or inflammatory process at the time of sampling
- Active oral bleeding or evident blood contamination of the salivary swab Invasive dental procedures within the previous 2 weeks
- Systemic antibiotic therapy within the previous 2 weeks
- Inability to provide written informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Giada Anna Beltramini, Associate Professor, +39 02 5503 4422, giada.beltramini@policlinico.mi.it
Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
Matteo Pellegrini, DDS, +39 0382 516209, matteo.pellegrini02@universitadipavia.it
About this study
Official title: Salivary Interleukin-6 Levels and Interleukin Gene Polymorphisms for the Biological Stratification of Locoregional Progression in Oral Squamous Cell Carcinoma (OSCC): A Multicentre Observational Cross-Sectional Study
This observational study will evaluate whether salivary interleukin-6 levels and selected interleukin gene polymorphisms are associated with regional lymph node involvement in patients with oral squamous cell carcinoma.
Adult patients with histologically confirmed oral squamous cell carcinoma will be enrolled before receiving any cancer-specific treatment. Participants will be classified into two groups according to the presence or absence of regional lymph node metastasis: OSCC N0M0 and OSCC N+M0.
Read more
The study does not involve any experimental treatment and does not change the standard diagnostic or therapeutic pathway. Each participant will provide a saliva sample using a sterile absorbent swab. The saliva sample will be used to measure interleukin-6 levels. Available biological material will also be used to analyze selected interleukin gene polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN.
The aim of the study is to explore whether these salivary and genetic markers may help characterize different biological patterns of locoregional progression in oral squamous cell carcinoma.
Read the detailed description
Oral squamous cell carcinoma is characterized by variable biological behavior, including different patterns of regional lymph node involvement. Regional lymph node metastasis is one of the main prognostic factors in this disease. However, patients with similar clinicopathological characteristics may show different patterns of locoregional progression, suggesting that additional biological markers may help describe tumor behavior.
This multicentre observational cross-sectional study will investigate salivary interleukin-6 and selected interleukin gene polymorphisms in adult patients with histologically confirmed oral squamous cell carcinoma. Participants will be enrolled before any cancer-specific treatment and classified according to regional lymph node status as OSCC N0M0 or OSCC N+M0.
Saliva will be collected using a standardized sterile absorbent swab procedure. Salivary interleukin-6 levels will be quantified and expressed as pg/mL. Selected interleukin-related genetic polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN, will be analyzed from available biological material using validated molecular biology methods.
The primary objective is to compare salivary interleukin-6 levels between patients without regional lymph node metastasis and patients with regional lymph node metastasis. Secondary objectives include evaluating the association between nodal status and interleukin gene polymorphisms, and exploring the relationship between these polymorphisms and salivary interleukin-6 levels.
No experimental treatment will be administered, and participation will not modify the standard diagnostic or therapeutic management of oral squamous cell carcinoma.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Being tested
- Saliva Collection and Biomarker Analysis
- Keywords
- Oral squamous cell carcinoma, OSCC, Salivary interleukin-6, IL-6, Interleukin gene polymorphisms, Regional lymph node metastasis, Locoregional progression, Salivary biomarkers, Genetic biomarkers, IL6, IL1B, IL10, IL8, CXCL8, IL1RN, Tumor microenvironment
- Medical subject headings
- 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.
Saliva Collection and Biomarker AnalysisOther
Also called Salivary IL-6 Measurement; Interleukin Gene Polymorphism Analysis
Participants will undergo saliva sample collection using a sterile disposable absorbent salivary swab before any OSCC-specific oncological treatment. Salivary samples will be analyzed to measure interleukin-6 levels. Available biological material will also be used to analyze selected interleukin gene polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN. No experimental treatment will be administered, and the study procedures will not modify the standard diagnostic or therapeutic pathway.
| Study group | Role | What they receive |
|---|---|---|
| OSCC N0M0 | Adult patients with histologically confirmed oral squamous cell carcinoma of the oral cavity, without regional lymph node metastasis and without distant metastasis. Participants will undergo saliva sample collection before any OSCC-specific oncological treatment. No experimental intervention will be administered. Receives: Other: Saliva Collection and Biomarker Analysis | |
| OSCC N+M0 | Adult patients with histologically confirmed oral squamous cell carcinoma of the oral cavity, with regional lymph node metastasis and without distant metastasis. Participants will undergo saliva sample collection before any OSCC-specific oncological treatment. No experimental intervention will be administered. Receives: Other: Saliva Collection and Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients
Salivary interleukin-6 levels will be compared between patients with oral squamous cell carcinoma without regional lymph node metastasis, classified as OSCC N0M0, and patients with oral squamous cell carcinoma with regional lymph node metastasis, classified as OSCC N+M0. Salivary interleukin-6 will be measured from saliva samples collected using sterile absorbent swabs and expressed as a continuous variable in pg/mL.
Measured: Baseline, before any OSCC-specific oncological treatment
Secondary outcomes (2)
Association Between Regional Lymph Node Status and Interleukin Gene Polymorphisms
The association between regional lymph node status and selected interleukin gene polymorphisms will be evaluated by comparing genotype and/or allele frequencies of IL6, IL1B, IL10, IL8/CXCL8, and IL1RN between patients with OSCC N0M0 and patients with OSCC N+M0. Where appropriate, results will be expressed as odds ratios for regional lymph node metastasis.
Measured: Baseline, before any OSCC-specific oncological treatment
Association Between Interleukin Gene Polymorphisms and Salivary Interleukin-6 Levels
The association between selected interleukin gene polymorphisms and salivary interleukin-6 levels will be assessed by comparing salivary interleukin-6 concentrations across genotype groups and/or through regression models using salivary interleukin-6 as a continuous dependent variable. Salivary interleukin-6 will be expressed in pg/mL.
Measured: Baseline, before any OSCC-specific oncological treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692360
- Sponsor's protocol ID
- IL6-OSCC-2026
- Acronym
- IL6-OSCC
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Interleukin-6 Levels and Interleukin Gene Polymorphisms for the Biological Stratification of Locoregional Progression in Oral Squamous Cell Carcinoma (OSCC): A Multicentre Observational Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07692360
- Acronym / sponsor ID
- IL6-OSCC / IL6-OSCC-2026
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Keywords
- Oral squamous cell carcinoma, OSCC, Salivary interleukin-6, IL-6, Interleukin gene polymorphisms, Regional lymph node metastasis, Locoregional progression, Salivary biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Jul 2026 (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.
This observational study will evaluate whether salivary interleukin-6 levels and selected interleukin gene polymorphisms are associated with regional lymph node involvement in patients with oral squamous cell carcinoma.
Adult patients with histologically confirmed oral squamous cell carcinoma will be enrolled before receiving any cancer-specific treatment. Participants will be classified into two groups according to the presence or absence of regional lymph node metastasis: OSCC N0M0 and OSCC N+M0.
The study does not involve any experimental treatment and does not change the standard diagnostic or therapeutic pathway. Each participant will provide a saliva sample using a sterile absorbent swab. The saliva sample will be used to measure interleukin-6 levels. Available biological material will also be used to analyze selected interleukin gene polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN.
The aim of the study is to explore whether these salivary and genetic markers may help characterize different biological patterns of locoregional progression in oral squamous cell carcinoma.
Detailed description
Oral squamous cell carcinoma is characterized by variable biological behavior, including different patterns of regional lymph node involvement. Regional lymph node metastasis is one of the main prognostic factors in this disease. However, patients with similar clinicopathological characteristics may show different patterns of locoregional progression, suggesting that additional biological markers may help describe tumor behavior.
This multicentre observational cross-sectional study will investigate salivary interleukin-6 and selected interleukin gene polymorphisms in adult patients with histologically confirmed oral squamous cell carcinoma. Participants will be enrolled before any cancer-specific treatment and classified according to regional lymph node status as OSCC N0M0 or OSCC N+M0.
Saliva will be collected using a standardized sterile absorbent swab procedure. Salivary interleukin-6 levels will be quantified and expressed as pg/mL. Selected interleukin-related genetic polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN, will be analyzed from available biological material using validated molecular biology methods.
The primary objective is to compare salivary interleukin-6 levels between patients without regional lymph node metastasis and patients with regional lymph node metastasis. Secondary objectives include evaluating the association between nodal status and interleukin gene polymorphisms, and exploring the relationship between these polymorphisms and salivary interleukin-6 levels.
No experimental treatment will be administered, and participation will not modify the standard diagnostic or therapeutic management of oral squamous cell carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSCC N0M0 | – | Other: Saliva Collection and Biomarker AnalysisAdult patients with histologically confirmed oral squamous cell carcinoma of the oral cavity, without regional lymph node metastasis and without distant metastasis. Participants will undergo saliva sample collection before any OSCC-specific oncological treatment. No experimental intervention will be administered. |
| OSCC N+M0 | – | Other: Saliva Collection and Biomarker AnalysisAdult patients with histologically confirmed oral squamous cell carcinoma of the oral cavity, with regional lymph node metastasis and without distant metastasis. Participants will undergo saliva sample collection before any OSCC-specific oncological treatment. No experimental intervention will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients with histopathologically confirmed oral squamous cell carcinoma of the oral cavity, enrolled before any OSCC-specific oncological treatment. Participants will be classified according to regional lymph node status into two observational cohorts: OSCC N0M0, defined as absence of regional lymph node metastasis and absence of distant metastasis, and OSCC N+M0, defined as presence of regional lymph node metastasis and absence of distant metastasis. Patients will be recruited from participating Italian study centres involved in the clinical management of oral squamous cell carcinoma.
Key inclusion criteria (9 listed)
- Age 18 years or older
- Histopathologically confirmed diagnosis of oral squamous cell carcinoma of the oral cavity
- Oral squamous cell carcinoma site excluding oropharyngeal sites
- Defined regional lymph node status allowing classification as OSCC N0M0 or OSCC N+M0
- Absence of distant metastasis, classified as M0
Key exclusion criteria (12 listed)
- Age younger than 18 years
- Oral squamous cell carcinoma involving oropharyngeal sites
- Presence of distant metastasis
- Previous OSCC-specific oncological treatment before saliva sample collection
- Acute infection at the time of sampling or within the previous 2 weeks
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 |
|---|---|---|
| Saliva Collection and Biomarker AnalysisAlso: Salivary IL-6 Measurement; Interleukin Gene Polymorphism AnalysisParticipants will undergo saliva sample collection using a sterile disposable absorbent salivary swab before any OSCC-specific oncological treatment. Salivary samples will be analyzed to measure interleukin-6 levels. Available biological material will also be used to analyze selected interleukin gene polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN. No experimental treatment will be administered, and the study procedures will not modify the standard diagnostic or therapeutic pathway. | Other | OSCC N+M0, OSCC N0M0 |
Primary outcome
Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients
Time frame: Baseline, before any OSCC-specific oncological treatment
Salivary interleukin-6 levels will be compared between patients with oral squamous cell carcinoma without regional lymph node metastasis, classified as OSCC N0M0, and patients with oral squamous cell carcinoma with regional lymph node metastasis, classified as OSCC N+M0. Salivary interleukin-6 will be measured from saliva samples collected using sterile absorbent swabs and expressed as a continuous variable in pg/mL.
2 secondary outcomes
Association Between Regional Lymph Node Status and Interleukin Gene Polymorphisms
Time frame: Baseline, before any OSCC-specific oncological treatment
Association Between Interleukin Gene Polymorphisms and Salivary Interleukin-6 Levels
Time frame: Baseline, before any OSCC-specific oncological treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma (OSCC), run by University of Pavia at 2 sites in Italy.
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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Pellegrini, DDS (+39 0382 516209, matteo.pellegrini02@universitadipavia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients (time frame: Baseline, before any OSCC-specific oncological treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.