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临床试验/NCT05093400
NCT05093400已完成不适用

Oropharynx (OPX) Salivary Biomarker Study: Microbiome, Virome, and Metabolomics

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
100
试验地点
1
主要终点
Oncologic strains in HPV DNA salivary samples

研究概览

简要总结

The goal of this study is to analyze certain biomarkers to look at the relationship between HPV in the saliva, stage at presentation, and a potential self-test compared to saliva of non-cancerous participants.

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

入选标准

  • Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).
  • Normal Controls:
  • Age ≥ 18 years;
  • Able to provide informed written consent documenting permission to give saliva sample for research testing.;
  • Ability to complete questionnaire(s) by themselves or with assistance.

排除标准

  • Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).
  • Normal Controls:
  • Any personal history of head or neck cancer including head or neck skin cancer.
  • Other active malignancy ≤ 5 years prior to registration.
  • EXCEPTIONS: Non-melanotic skin cancer, non-metastatic prostate cancer.
  • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
  • Dry mouth (xerostomia) caused by any chronic (>30 days) condition (known or unknown) or medication.
  • Recent (within 30 days) or active upper aerodigestive tract or anogenital infections.

结局指标

主要结局

Oncologic strains in HPV DNA salivary samples

时间窗: 2 years

Number of patients to have oncologic strains of HPV DNA in salivary samples

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathryn (Katie) M. Van Abel

Principal Investigator

Mayo Clinic

研究点 (1)

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Oropharynx (OPX) Salivary Biomarker Study | 临床试验