- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00043238
Mohawk Culture, Behavior, Toxicant Exposure and Health
April 13, 2015 updated by: National Institute of Environmental Health Sciences (NIEHS)
This study will determine the pathways between Mohawk cultural identification and specific behaviors related to pollutant exposure, and determine the effects of these factors and the pollutant exposure on physiologically and socially significant outcomes.
Study Overview
Status
Completed
Conditions
Detailed Description
Considerable concern now exists over possible effects on human physical and psychological development of endocrine disrupting environmental contaminants such as polychlorinated biphenyls (PCBs).
Native American communities are particularly at risk owing to subsistence systems and a cultural ethos involving greater contact with the physical environment.
The proposed study follows-up 220 Mohawk adolescents aged 17-21 years, who participated in a previous study when they were 10-16 years old.
All adolescents are members of the Mohawk Nation at Akwesasne which is located on the St. Lawrence River and is adjacent to hazardous waste sites where PCBs have contaminated the local ecology.
The investigation examines the interrelationship between Mohawk cultural identity, traditional Mohawk customs, behaviors related to toxicant exposure and current toxicant burden.
Serum level of PCBs will be assessed by congener specific analysis.
The study will determine the relationship of congeners and their hydroxylated metabolites to thyroid function (levels of triiodothyronine, free triiodothyronine, thyroxine, free thyroxine, thyrotropin and anti-thyroid antibodies), and 2) psychosocial outcomes including school behavior and performance, hyperactivity, and adaptation to the community.
Data gathered for the past study will be employed to assess variation in metabolism of PCBs, as well as how earlier measures of cognition and hyperactivity relate to 17 year old psychosocial outcomes.
Variation in susceptibility to PCB effects will be determined by examining the effects of concurrent toxicant exposure (hexachlorobenzene, Mirex, dichlorodiphenyldichloroethene, lead), diet, and indicators of PCB metabolism, on the focal measures of adult functioning.
The proposed study will clarify the causal pathways between culturally identifying behavior, PCB exposure and body burden, thyroid functioning, cognitive functioning, social behavior and school functioning while identifying activities that are important to maintain cultural identify and unrelated to exposure.
Study Type
Observational
Enrollment (Anticipated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Akwesasne, New York, United States, 13655
- First Environments Research Project Office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Participation in previous study of Mohawk adolescent well-being is required for participation in this project.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (ACTUAL)
July 1, 2005
Study Completion (ACTUAL)
July 1, 2005
Study Registration Dates
First Submitted
August 7, 2002
First Submitted That Met QC Criteria
August 7, 2002
First Posted (ESTIMATE)
August 8, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
April 14, 2015
Last Update Submitted That Met QC Criteria
April 13, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10904-CP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Diseases
-
Aarhus University HospitalOdense University Hospital; University of AarhusEnrolling by invitationThyroid Cancer | Thyroid Nodule (Diagnosis)Denmark
-
AllerganCompletedHypothyroidism | Thyroid Disease | Euthyroid | Thyroid Gland | Thyroid HormonesUnited States
-
Wuhan UniversityRecruitingThyroid Carcinoma | Thyroid Nodule (Benign) | Ablation; RetinaChina
-
National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
-
Rigen BiotechRenJi Hospital; Tianjin Medical University Cancer Institute and Hospital; Guangdong... and other collaboratorsRecruitingThyroid Cancer | Thyroid NoduleChina
-
University of FloridaNational Cancer Institute (NCI)RecruitingThyroid Cancer | Thyroid NodulesUnited States
-
Inha University HospitalRecruitingThyroid Cancer | Thyroid NoduleKorea, Republic of
-
Shanghai 10th People's HospitalUnknown
-
Boston Medical CenterCompletedThyroid Neoplasms | Thyroid Cancer | Thyroid NoduleUnited States
-
Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States