Role of Human Microbiome in Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Characterize human dysbiosis
研究概览
简要总结
This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
详细描述
HNSCCis a lethal cancer with a 5-year survival rate below 50%. Although smoking, alcohol intake, and human papillomavirus (HPV) infection are linked to HNSCC, only a small proportion of individuals exposed to these factors develop cancer and not all cases progress. Thus, additional environmental or host factors must contribute to HNSCC. The Study Team and others have observed significant oral dysbiosis in human HNSCC cases, both before and after treatment. This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects equal to or above the age of
- •Patients who are seen and evaluated by a provider within the adult Otolaryngology clinic at the University of Colorado Health.
- •Patients that present with a diagnosis of OSCC.
- •An equal number of age-matched patients who are visiting the clinic for reasons other than OSCC diagnoses, as the control group.
- •Ability to understand and willingness to sign a written informed consent document
排除标准
- •Subjects under the age of 18 or over the age of 100
- •Subjects unwilling to particiapte
研究组 & 干预措施
Non Oral Squamous Cell Carcinoma Stool Sample Group
Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).
干预措施: Metagenomic sequencing (Diagnostic Test)
Oral Squamous Cell Carcinoma Saliva Sample Group
Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at
-80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.
干预措施: Metagenomic sequencing (Diagnostic Test)
Oral Squamous Cell Carcinoma Saliva Sample Group
Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at
-80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.
干预措施: Metabolic analysis (Diagnostic Test)
Non Oral Squamous Cell Carcinoma Saliva Sample Group
Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at
-80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.
干预措施: Metagenomic sequencing (Diagnostic Test)
Non Oral Squamous Cell Carcinoma Saliva Sample Group
Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at
-80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.
干预措施: Metabolic analysis (Diagnostic Test)
Oral Squamous Cell Carcinoma Stool Sample Group
Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).
干预措施: Metagenomic sequencing (Diagnostic Test)
Oral Squamous Cell Carcinoma Stool Sample Group
Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).
干预措施: Metabolic analysis (Diagnostic Test)
Non Oral Squamous Cell Carcinoma Stool Sample Group
Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).
干预措施: Metabolic analysis (Diagnostic Test)
结局指标
主要结局
Characterize human dysbiosis
时间窗: Day 1
Stool and saliva samples will be collected from participants, allowing us to reproduce human dysbiosis and analyze whether HNSCC affects one's microbiome composition. Metagenomic sequencing will be conducted through use of DNA extraction, library generation and Illumina sequencing. At least 30 million paired-end 2x150bp metagenomic reads will be generated per sample using the Illumina NovaSeq platform.
Characterize human metabolomics
时间窗: Day 1
Through our stool and saliva samples we will be able to characterize metagenomic and metabolic signatures in treatment naïve OSCC and non-OSCC patients. Metabolic analysis will be conducted using LC/MS-based metabolic analysis. A targeted approach will quantify a panel of 30 componds including Trp pathway products, while a non-targeted approach, when applied to both lipid and aqueous phase compounds, will profile relative changes in compounds that may influence host and metabolic and immune statuses.
Integrative multi-omic data analysis and biomarker discovery
时间窗: Day 365
We expect to find that specific sets of microbial and host factors interact with each other to promote OSCC.
次要结局
- Impact of human dysbiosis on OSCC development in mice(Day 10-Day 100)
- Monitor tumor size(Day 10-Day 100)