Amplification of Merkel Cell Polyomavirus From Skin Swabs

June 30, 2017 updated by: National Cancer Institute (NCI)

Amplification of Merkel Cell Polyomavirus From Skin Swab Specimens

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI), 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • Study participants will be drawn from LCO co-workers in Building 37 Rooms 4106-4134. LCO members will be invited to participate without regard to gender, race, sexual orientation, or ethnic background.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2009

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 19, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 999909219
  • 09-C-N219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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