跳至主要内容
临床试验/NCT00977990
NCT00977990已完成不适用

Amplification of Merkel Cell Polyomavirus From Skin Swab Specimens

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1

研究概览

简要总结

Background:

  • Polyomavirus are DNA-based viruses that infect vertebrates, including humans. Most people are not harmed by polyomavirus infection, but people with compromised immune systems may be harmed by these viruses, and are at greater risk for developing certain types of rare cancers.
  • A recently discovered virus called Merkel cell polyomavirus (MCV) is a type of skin infection commonly found in humans. By using skin swabs to collect MCV, researchers hope to develop a laboratory culture model of MCV for future research.

Objectives:

  • To use skin swabs to collect samples of Merkel cell polyomavirus for future study.

Eligibility:

  • Individuals 18 years of age and older who are employed in the National Cancer Institute's Laboratory of Cellular Oncology.

Design:

  • Participants will wipe a cotton swab across their forehead and eyebrows, and break off the end of the swab into a microcentrifuge tube. This procedure will be performed after work hours.
  • No other treatment or procedure will be given as part of this protocol.

详细描述

Polyomaviruses are a class of DNA-based viruses that infect vertebrates, including humans. A majority of humans are chronically infected with multiple polyomavirus types. In immunocompetent subjects, chronic polyomavirus infection is generally harmless. A recently-discovered virus called Merkel cell polyomavirus (MCV) is believed to chronically infect the skin of a substantial fraction of adult subjects. It has recently been shown that MCV DNA can be amplified from skin swab specimens using PCR methods. The goal of our study is to recover full-length (5.5 kb) MCV genomes from skin swab specimens taken from healthy laboratory volunteers. We will recombine any recovered MCV genomes and attempt to propagate them in cell culture. If successful, the work would provide the first laboratory culture model for MCV replication. The recombinant DNA work has received approval from the NIH Institutional Biosafety Committee

Our study population would be drawn from roughly two dozen co-workers in the Lab of Cellular Oncology's Building 37 Sections. LCO co-workers are an appealing study population because they are generally familiar with the biology of MCV. Candidate study participants will be reminded that, given the high prevalence of asymptomatic MCV infection among healthy adults, the detection of MCV DNA in skin swabs clearly cannot be construed as having any diagnostic, clinical or social significance.

Subjects who agree to participate in the study will wipe a cotton swab across their forehead and eyebrows. Study subjects will break off the end of the swab into a microcentrifuge tube. To avoid study participation during federal work hours, the specimen collection will be performed prior to or after the study subject's work shift. Each sample will be assigned a letter code. A key for the letter code will exist only in Dr. Buck's secure NCI server space.

Given the non-invasive nature of the sampling and the clear lack of potential harm arising from study participation, the proposal appears to be eligible for expedited review by the IRB's Special Studies section.

研究设计

研究类型
Observational
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (1)

Loading locations...

相似试验