Sister-chromatic-exchange(SCE)NCT01253057
A Research on the Hospital Pollution Control and Hygine Intervention of Chemotherapy Drugs Exposure
An observational study of Sister-chromatic-exchange(SCE) and Micronuclei(MN), run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Several epidemiological studies found that exposure to antineoplastic agents were associated with some reproductive, carcinogenic effects, higher rates of advance micronuclei (MN), sister-chromatic-exchange (SCE) and spontaneous abortion. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sister-chromatic-exchange(SCE), Micronuclei(MN)
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2010to Dec 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: cleaning staff
Who may be able to join
- Only included those who signed the consent study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Several epidemiological studies found that exposure to antineoplastic agents were associated with some reproductive, carcinogenic effects, higher rates of advance micronuclei (MN), sister-chromatic-exchange (SCE) and spontaneous abortion. Cleaning staff were potentially exposed to these agents while cleaning ward, ward toilet or other area.
One medical center and one area hospitals in Taipei.Surface wipe samples were collected in the cleaning staff work area, such as ward environment and ward toilet. Urine and blood samples of subjects were collected for exposure examinations. Platinum-containing drugs (Cisplatin, Carboplatin, Oxaliplatin) were used as indicator drugs in environmental (surface wipe samples) and biological (urine and blood samples) samples.
Read more
A self-administered questionnaire was used to collect demographic data, working practices, medical and contact history, and perceived work-related symptoms of cleaning staff.
The results of this study will be to reduce exposure to cleaning staff.
- Conditions
- Sister-chromatic-exchange(SCE), Micronuclei(MN)
- Keywords
- cleaning staff, antineoplastic agents
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 |
|---|---|---|
| Experimental Group | Not described | |
| Control Group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startOct 2010
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sister-chromatic-exchange(SCE)Studies 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
- Case-control
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ruey-Yu Chen, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253057
- Sponsor's protocol ID
- 99061
- Status last verified
- Dec 2010
- First submitted
- 1 Dec 2010
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research on the Hospital Pollution Control and Hygine Intervention of Chemotherapy Drugs Exposure
- ClinicalTrials.gov ID
- NCT01253057
- Acronym / sponsor ID
- 99061
- Conditions
- Sister-chromatic-exchange(SCE), Micronuclei(MN)
- Keywords
- cleaning staff, antineoplastic agents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 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.
Several epidemiological studies found that exposure to antineoplastic agents were associated with some reproductive, carcinogenic effects, higher rates of advance micronuclei (MN), sister-chromatic-exchange (SCE) and spontaneous abortion. Cleaning staff were potentially exposed to these agents while cleaning ward, ward toilet or other area.
One medical center and one area hospitals in Taipei.Surface wipe samples were collected in the cleaning staff work area, such as ward environment and ward toilet. Urine and blood samples of subjects were collected for exposure examinations. Platinum-containing drugs (Cisplatin, Carboplatin, Oxaliplatin) were used as indicator drugs in environmental (surface wipe samples) and biological (urine and blood samples) samples.
A self-administered questionnaire was used to collect demographic data, working practices, medical and contact history, and perceived work-related symptoms of cleaning staff.
The results of this study will be to reduce exposure to cleaning staff.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | – |
| Control Group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cleaning staff
Key inclusion criteria (1 listed)
- Only included those who signed the consent study
Key exclusion criteria (1 listed)
- none
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
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.
Ruey-Yu Chen principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sister-chromatic-exchange(SCE) and Micronuclei(MN), run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
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.
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 3 Dec 2010.