Exposure to Photocopiers on a Professional BasisNCT01267799
Health Status of Workers in Photocopier Units
An observational study of Exposure to Photocopiers on a Professional Basis, run by Avinashilingam Deemed University at 3 sites in India.
Trial summary
Photocopiers are indispensable in today's working environment. However, photocopiers emit a number of harmful chemicals during their operation. Photocopier toners also contain a number of potentially toxic substances. Chronic exposure to these substances may compromise the health of photocopier operators. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposure to Photocopiers on a Professional Basis
- How many people
- 160 participants
- Where
- 3 sitesIndia
- Study dates
- Jul 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: exposure to photocopier emissions
Who may be able to join
- Exposure to photocopier emissions for minimum 2 years professionally
Who cannot join
- Any clinical abnormality
Trial locations and contacts
3 sites in 1 country.
India3 sites
Avinashilingam Deemed University for Women
Coimbatore, Tamil Nadu, 641 043
Avinashilingam Deemed University
Coimbatore, Tamil Nadu, 641043
Study site
Coimbatore, Tamil Nadu, 641043
About this study
Official title: Correlation Between Pulmonary Function and Selected Serum/Sputum Biomarkers of Pulmonary Damage Among Workers in Photocopier Units
Photocopiers are indispensable in today's working environment. However, photocopiers emit a number of harmful chemicals during their operation. Photocopier toners also contain a number of potentially toxic substances. Chronic exposure to these substances may compromise the health of photocopier operators. This study is aimed to understand if chronic exposure to photocopier emissions is harmful to human health.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| photocopier exposure | Not described | |
| control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if photocopier emissions are toxic to human health
Measured: 2 years
Secondary outcomes (1)
To assess the best biomarker for pulmonary damage in serum
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Photocopiers on a Professional BasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avinashilingam Deemed University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Nithya, Avinashilingam Deemed University
- Investigators
- Jeyanthi G P, Ph.D, Study director, Avinashilingam Deemed University for Women
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267799
- Sponsor's protocol ID
- photocopiers
- Status last verified
- Jun 2017
- First submitted
- 28 Dec 2010
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pulmonary Function and Selected Serum/Sputum Biomarkers of Pulmonary Damage Among Workers in Photocopier Units
- ClinicalTrials.gov ID
- NCT01267799
- Acronym / sponsor ID
- photocopiers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Avinashilingam Deemed UniversityUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Photocopiers are indispensable in today's working environment. However, photocopiers emit a number of harmful chemicals during their operation. Photocopier toners also contain a number of potentially toxic substances. Chronic exposure to these substances may compromise the health of photocopier operators. This study is aimed to understand if chronic exposure to photocopier emissions is harmful to human health.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| photocopier exposure | – | – |
| control | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- exposure to photocopier emissions
Key inclusion criteria (1 listed)
- Exposure to photocopier emissions for minimum 2 years professionally
Key exclusion criteria (1 listed)
- Any clinical abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess if photocopier emissions are toxic to human health
Time frame: 2 years
1 secondary outcome
To assess the best biomarker for pulmonary damage in serum
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeyanthi G P, Ph.D study director
Avinashilingam Deemed University for Women
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure to Photocopiers on a Professional Basis, run by Avinashilingam Deemed University at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if photocopier emissions are toxic to human health (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.