A Research on the Hospital Pollution Control and Hygine I... | NCT01253057

Studies
A Research on the Hospital Pollution Control and Hygine Intervention of Chemotherapy Drugs Exposure

NCT01253057

Sponsor

Taipei Medical University WanFang Hospital

Status

Unknown status

Last Update Posted

Dec 3, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Sister-chromatic-exchange(SCE)
Micronuclei(MN)

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Not provided

Completion Date

Dec 2011Estimated

First Submitted Date

Dec 1, 2010

First Submission Date that Met QC Criteria

Dec 1, 2010

First Posted Date

Dec 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2010

Last Update Posted Date

Dec 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Only included those who signed the consent study

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

cleaning staff

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruey-Yu Chen	Taipei Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University WanFang Hospital		Taipei			Taiwan

Label	Type	Description	Intervention Names
Experimental Group
Control Group