Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)
研究概览
详细说明
To assess the feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods: Saliva, Oropharyngeal swab over the tumor site (OP), Stool, and Rectal swab (optional).
This study is investigating the role of oral microbiota as a biomarker in LA-OPSCC. This is a minimal risk study involving the analysis of patient samples and does not involve therapeutic intervention. This protocol does not determine eligibility to receive treatment with concurrent radiotherapy and chemotherapy. It is anticipated that patient accrual will be completed within 12 months.
The study will involve a prospective cohort of up to 60 patients diagnosed with LA OPSCC treated with CRT at Princess Margaret Cancer Center.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G 2M9
- Princess Margaret Cancer Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Signed written and voluntary informed consent.
- Patient must be willing and able to provide collection for saliva, OP swab and stool specimen analyses at 2 time points. Rectal swab is optional.
- Age > 18 years, male or female.
- Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue).
- Patients must be eligible for curative-intent concurrent treatment with radiotherapy and chemotherapy.
Exclusion Criteria:
- Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods
大体时间：1 year
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To assess the feasibility, the endpoint will be the proportion of analyzable samples.
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1 year
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Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods
大体时间：1 year
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To assess the feasibility, the endpoint will be the patient compliance rate with sample collection timeline/procedures.
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1 year
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of the relationship between oral and intestinal microbiome composition and diversity in LA-OPSCC patients undergoing CRT.
大体时间：1 year
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To evaluate this relationship, the samples will undergo the following analyses: DNA extraction, 16S rRNA amplification, and Illumina MiSeq Sequencing
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1 year
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合作者和调查者
调查人员
- 首席研究员：Anna Spreafico, MD、Princess Margaret Cancer Centre
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.