NCT00023140

Brief Summary

Butadiene is a suspect human carcinogen to which most people are exposed daily. Exposures are difficult to measure by air sampling. This study examines the relationship between air levels and several biomarkers of exposure. Biomarkers are substances analyzed in human tissues or waste products. Adducts are materials formed when a chemical reacts with a biological material. In this study we are looking at biomarkers in the blood: hemoglobin and DNA adducts, and urinary metabolites. If a strong relationship is found then the amounts of biomarkers in a person's blood or urine can tell us how much they have been exposed. The tests are being conducted on petrochemical workers who have a wide range of exposures to butadiene. An international group of investigators is conducting the study.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 1999

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 1999

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

August 22, 2001

Last Update Submit

April 13, 2015

Conditions

Cancer

Keywords

biomarkersexposureadductsmetabolitesbutadiene

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Healthy adults without metabolic disorders

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

National Chung Kung University

Tainan, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 22, 2001

First Posted

August 24, 2001

Study Start

July 1, 1999

Primary Completion

May 1, 2002

Study Completion

June 1, 2002

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

TW(1)US(1)