Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma (IL6-OSCC)
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.
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Matteo Pellegrini, DDS
- 電話番号：+39 0382 516209
- メール：matteo.pellegrini02@universitadipavia.it
研究場所
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Lombardy
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Milan、Lombardy、イタリア、20122
- Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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コンタクト：
- Giada Anna Beltramini, Associate Professor
- 電話番号：+39 02 5503 4422
- メール：giada.beltramini@policlinico.mi.it
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Pavia、Lombardy、イタリア、27100
- Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
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コンタクト：
- Matteo Pellegrini, DDS
- 電話番号：+39 0382 516209
- メール：matteo.pellegrini02@universitadipavia.it
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
他の名前：
|
|
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.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients
時間枠：Baseline, before any OSCC-specific oncological treatment
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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.
|
Baseline, before any OSCC-specific oncological treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Association Between Regional Lymph Node Status and Interleukin Gene Polymorphisms
時間枠：Baseline, before any OSCC-specific oncological treatment
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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.
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Baseline, before any OSCC-specific oncological treatment
|
|
Association Between Interleukin Gene Polymorphisms and Salivary Interleukin-6 Levels
時間枠：Baseline, before any OSCC-specific oncological treatment
|
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.
|
Baseline, before any OSCC-specific oncological treatment
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IL6-OSCC-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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