NCT01599845

Brief Summary

Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

April 29, 2012

Last Update Submit

May 14, 2012

Conditions

Inadequate or Impaired Respiratory Function

Keywords

LungAlveoliNanoparticlesParticulate matterExhaled breath condensateInduced sputumForced expiratory volumeForce vital capacity

Outcome Measures

Primary Outcomes (1)

  • Analysis of the size distribution of nano-particles in exhaled breath condensate

    Each subject will be examined once. The total time for collection of data is estimated as about one year.

    One year

Study Arms (1)

Nanoparticle exposed

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients

You may qualify if:

  • Adults over 20 years of age who visit Ichilov Hospital for medical complaints/inquiries regarding respiratory tract.
  • Study population is composed of people who are exposed to environmental particles form industrial sources.
  • Informed consent is requested from each subject.

You may not qualify if:

  • Unemployed individuals.
  • Individuals who are not working in industrial jobs, such as office workers and secretaries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Yehuda Schwarz, M.D.

    Tel Aviv Sourasky Medical Center (TASMC, Ichilov)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yehuda Schwarz, M.D.

CONTACT

03-6973774schwarz.reot@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2012

First Posted

May 16, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

May 1, 2013

Last Updated

May 16, 2012

Record last verified: 2012-05