NCT00023114

Brief Summary

The purpose of this project is to do cross species comparisons of the metabolism and toxicity of a number of toxicants which require metabolism for toxicity. All of the toxicants in question are encountered by humans in the workplace, through lifestyle choices (cigarette smoking) and as a result of environmental contamination. The high incidence of pulmonary diseases in the human population means that it will be difficult if not impossible to determine whether humans are at risk from exposure to these chemicals without solid mechanistic data. Recent rodent bioassays suggest that these compounds have oncogenic potential further supporting the need to test the potential for injury in primates. As part of this testing, we intend to establish in vitro methods for assessing critical steps in the metabolism of these agents and their interaction with cellular macromolecules. Once this is done, similar studies can be conducted in Rhesus or in human lung tissue that is available because it cannot be used for transplant purposes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2000

Shorter than P25 for all trials

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

September 1, 2000

Completed
12 months 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 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
Last Updated

September 4, 2006

Status Verified

September 1, 2006

First QC Date

August 22, 2001

Last Update Submit

September 1, 2006

Conditions

Pulmonary Disease

Keywords

lung functionsmokingmetabolism

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
All available organ donors in the Sacramento area

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

Sponsors & Collaborators

MeSH Terms

Conditions

Lung DiseasesSmoking

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 22, 2001

First Posted

August 24, 2001

Study Start

September 1, 2000

Study Completion

September 1, 2001

Last Updated

September 4, 2006

Record last verified: 2006-09