Oral Microbiome and Pancreatic Cancer
Oral Microbiome and Pancreatic Cancer: a Prospective Case-Control Study
This is a prospective population based study to examine the relationship of oral and pancreatic microbiome, and their functions, to pancreatic cancer risk.
The identification of specific oral bacteria and their functional relationship to pancreatic cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could provide a new microbially-based research paradigm, possibly leading to new drug targets for this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic preventions, with antibiotic therapy aimed at eradicating the specific species associated with increased cancer risk or, alternatively, combined with probiotics to introduce species that are associated with a decreased cancer risk. Thus, the study outcomes will lead to actionable means for pancreatic cancer prevention.
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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New York
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New York、New York、美国、10016
- New York University School of Medicine
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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:
- DNA extracted from oral wash samples from NIH-PLCO and ACS-CPS cohorts
Exclusion Criteria:
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学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Cases
subjects with histology-confirmed incident pancreatic cancer, with no prior history of cancer (except non-melanoma skin cancer), a valid consent, and pre-diagnostic oral wash samples.
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extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit.
16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab.
Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.
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Control
selected by incidence density sampling63 among cohort members who had no cancer prior to selection, provided a valid consent and an oral wash.
Controls were frequency matched to cases by cohort, age at cohort entry (5 year), sex, race, and calendar year of cohort entry.
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extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit.
16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab.
Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.
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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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Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.
大体时间：4 Years
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For the taxa present at both sites, correlation between the abundance of taxa will be examined between the two sites.
To adjust for confounders, multivariate linear regression will be used with abundance of oral taxa (exposure) and that of pancreas taxa (outcome).
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4 Years
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合作者和调查者
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.
16S rRNA gene sequencing assay的临床试验
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Hallym University Kangnam Sacred Heart Hospital招聘中
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Karaganda Medical UniversityMinistry of Education and Science, Republic of Kazakhstan完全的