Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The difference in bacterial composition between the tumor, healthy mucosa, and hypopharyngeal secretions will be assessed
研究概览
简要总结
Head and neck squamous cell carcinoma (HNSCC), France's 5th most common cancer (15,000 annual cases), presents significant public health challenges due to high morbidity and functional/aesthetic sequelae from treatments (mutilating surgery, radiotherapy, chemotherapy). Major risk factors, tobacco and alcohol, create a chronic inflammatory environment promoting tumor development. The upper aerodigestive tract microbiome, influenced by these exposures and local alterations (necrosis, bleeding, ulcerations), is emerging as a potential factor in tumor progression, severity biomarker, or therapeutic target, though its exact role (cause or consequence) remains to be elucidated
Objectives:
- Primary: Compare bacterial microbiome composition between tumor tissue, adjacent healthy mucosa, and pharyngeal secretions
- Secondary:
- Correlate microbiome diversity/composition with clinical and epidemiological characteristics
- Identify microbiome variations by tumor stage, histology, and infiltration
- Discover diagnostic/prognostic microbial markers
- Analyze somatic variants (SNP/CNV) via whole-genome sequencing (WGS) and their association with microbiome profiles and clinical parameters
Study Design: Prospective, cross-sectional study with paired design (each patient serves as their own control to minimize genetic variation biases)
Methods:
- Samples: Tumor, adjacent healthy tissue, and pharyngeal secretions (3 samples/patient)
- Sequencing: Metagenomic sequencing (complete bacterial genomes) when biomass permits, or targeted 16S rRNA sequencing to identify dominant genera.
- Pilot study: 20 patients to select the optimal technique and validate feasibility, particularly assessing DNA quantity in these low-biomass environments
Population: Adults with suspected HNSCC scheduled for panendoscopy
Exclusion criteria: Recent antibiotics/corticosteroids (12 weeks), immunosuppression (uncontrolled HIV, active hematologic malignancies, autoimmune diseases on immunosuppressants, organ/stem cell transplants, uncontrolled diabetes), immunomodulatory treatments (3 months), recurrence, pregnancy, non-French speakers, legal guardianship, or lack of social security.
Safety: No additional risks beyond standard panendoscopy.
Expected impact: This approach may pave the way for innovative diagnostic or therapeutic strategies based on microbiome modulation in HNSCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Consultation in the ENT department for suspected squamous cell carcinoma of the upper aerodigestive tract scheduled for panendoscopy
- •Patient has provided consent to participate in the study and signed an informed consent form
排除标准
- •Antibiotic or corticosteroid therapy within 12 weeks prior to consultation
- •Conditions associated with immunosuppression:
- •Uncontrolled HIV infection (CD4 < 200 cells/µL) (permanent exclusion)
- •Hematologic malignancies currently under treatment or not in complete remission for <2 years
- •Autoimmune diseases under immunosuppressive treatment
- •Solid organ or stem cell transplant recipients (permanent exclusion)
- •Poorly controlled diabetes (HbA1c > 9%)
- •Immunomodulatory treatment within 3 months prior to consultation:
- •Immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1, anti-CTLA-4)
- •Biotherapy targeting the immune system (anti-TNF, anti-IL, calcineurin inhibitors, antimetabolites)
- •Recurrent upper aerodigestive tract cancer previously treated with surgery and/or radiochemotherapy
- •Pregnancy (confirmed prior to panendoscopy)
- •Patient who does not speak or understand French
- •Subject under guardianship or curatorship
- •Subject not affiliated with the national health insurance system
研究组 & 干预措施
Microbiome in head and neck squamous cell carcinoma Patients
Patients with suspected head and neck squamous cell carcinoma undergoing panendoscopy with additional biopsy sampling of tumor tissue, adjacent healthy mucosa, and pharyngeal secretions for microbiome analysis
干预措施: Tissue and secretion sampling via biopsy (Diagnostic Test)
Microbiome in head and neck squamous cell carcinoma Patients
Patients with suspected head and neck squamous cell carcinoma undergoing panendoscopy with additional biopsy sampling of tumor tissue, adjacent healthy mucosa, and pharyngeal secretions for microbiome analysis
干预措施: Tissue and secretion sampling via biopsy (Procedure)
结局指标
主要结局
The difference in bacterial composition between the tumor, healthy mucosa, and hypopharyngeal secretions will be assessed
时间窗: at day 1
次要结局
- Correlations between tumor microbiome diversity and composition and clinical/epidemiological data(at day 1)
- Differences in the tumor microbiome between subgroups defined by tumor stage, histological type, or infiltration, using differentiation tests(at day 1)
- Differential bacterial genera or strains between tumor, healthy, and pharyngeal microbiomes(at day 1)