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A Study of Breast Cancer, Breast Disease, Mammographic Density and Pesticides Among a Population From Triana, Alabama


N/A
35 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Study of Breast Cancer, Breast Disease, Mammographic Density and Pesticides Among a Population From Triana, Alabama


A DDT production plant in Alabama discharged large quantities of the pesticide into the
tributaries of the Tennessee River for several decades before it was discovered in the
1970's. A survey found that local primarily African-American, populations consuming fish
from the river had accumulated body burdens of the chemical that were orders of magnitude
above the general population. The settlement of law suits involving 1000 named plaintiffs
by the Federal District Court in Birmingham, AL led to the development of the Triana Area
Medical Fun, Inc. This fund provides 'health care and monitoring' for named plaintiffs as
well as other residents of Triana who, as of August 1983, had not asked the Court for
damages. The Board managing the activities of the Fund has given approval for this project.

The National Cancer Institute, in collaboration with the Triana Area Medical Fund and the
College of Nursing at the University of Alabama in Huntsville, is conducting a study to
investigate the possible effects of environmental exposures, such as the pesticide DDT and
other organochlorines compounds, on the risk of breast cancer. Individuals covered by the
Triana Area Medical Fund and other nearby residents were asked to participate.

The objective is to evaluate the risk of breast cancer associated with organochlorines
exposures among predominatly African-American women. This project is comprised of two major
components (1) comparison of blood serum levels of DDT, DDE and other organochlorines
compounds among members of the Triana Area Medical Fund population with a high percentage of
mammographic densities to women without this condition and (2) methodologic investigations
on organochlorines retention/decay patterns within the well-characterized Triana Area Fund
population.

The investigators offered mammographic screening to all women within the cohort over the age
of 35 (about 350), as well as others who requested it. As a service to the participants,
the investigators provided a standard clinical chemistry on blood samples and made the
results available to the subject and their physician, if they so chose. If individuals did
not have a regular physician, they were assisted in locating one to provide consultation and
interpretation of examination results. Standard blood chemistries were performed locally in
Alabama. The remainder of the blood sample was processed and sent to NCI for analysis and
storage. Serum analyses were conducted by the National Center for Environmental Health at
the CDC.

Results of the mammography, clinical examination and blood chemistries were provided to the
participants in a manner agreeable to each. If the subject wished, the results were sent to
her private physician. They made arrangements with several local hospitals to provide
follow-up evaluation and therapy for women with breast diseases uncovered by mammography who
lacked health insurance. Nurse practitioners or physicians involved in the study were
available to discuss and explain results. For women who required additional diagnostic
evaluation or therapy, they developed a follow back procedure to make sure appropriate
actions are being taken.

Data collection is complete. Two hundred twenty eight women received mammograms, a physical
examination, provided a serum sample (50 ml) and completed a questionnaire on diet and
lifestyle factors. During the past year the investigators obtained information on height
and weight, which is necessary to calculate body mass indices. Analyses of the data are
underway and manuscripts are being developed.

Inclusion Criteria


- INCLUSION CRITERIA:

Participants previously enrolled on protocols OH94-C-N024 and OH99-C-N035.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Robert N Hoover, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999904196

NCT ID:

NCT00341315

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Epidemiology
  • DDT
  • BMI
  • Serum
  • Case-Control Study
  • Breast Neoplasms
  • Breast Diseases

Name

Location

National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland  20892