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Breast CancerNCT00341315

Breast Cancer, Breast Disease, and Pesticides

An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will collect information on the height and weight of women who participated in a 1998 study in Triana, Alabama, on the risk of breast cancer and benign breast disease in relation to environmental exposure to the pesticide DDT and similar chemicals. Read more about this study

Who is it for?
Ages 35 to 80 years, women only
Conditions the study is for
Breast Cancer
How many people
228 participants
Where
1 siteUnited States
Study dates
17 May 2004to 30 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: A primarily African-American population living in the vicinity of a DDT production plant in Alabama.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama

    Birmingham, Alabama, 35233

Other trials in United States

About this study

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

This study will collect information on the height and weight of women who participated in a 1998 study in Triana, Alabama, on the risk of breast cancer and benign breast disease in relation to environmental exposure to the pesticide DDT and similar chemicals. This additional information is needed to calculate the participants' body mass index (BMI), which is required for completing analysis of the data.

The 1998 study-a collaborative effort of the National Cancer Institute, the Triana Area Medical Fund, and the College of Nursing at the University of Alabama at Huntsville-investigated possible effects of DDT and other compounds on the risk of breast cancer, predominantly among African-American women in the area of Triana, Alabama. The study was initiated as a result of medical findings showing high blood levels of DDT among the local population who had consumed fish from a tributary of the Tennessee River that had been polluted by the discharge over several decades of large quantities of pesticides from a DDT production plant.

Women participating in the study had a mammogram, physical examination, breast examination, and blood draw, and completed a questionnaire on diet and lifestyle factors. In order to complete analysis of the data and determine whether there is an association between environmental exposure to DDT and related chemicals and breast cancer risk, additional information on BMI is required.

Read the detailed description

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.

Conditions
Breast Cancer
Keywords
Epidemiology, DDT, BMI, Serum, Case-Control Study
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00341315
Study groupRoleWhat they receive
CohortA primarily African-American population living in the vicinity of a DDT production plant inAlabama.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DDT & DDE pesticide levels in blood

    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.

    Measured: 10 years +

Secondary outcomes (1)
  1. Mammogram

    Measured: 10 years +

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2006 (estimated)
  2. Study start17 May 2004
  3. Primary completion18 Apr 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00341315
Sponsor's protocol ID
999904196
Other IDs
04-C-N196
Status last verified
Apr 2020
First submitted
19 Jun 2006
Last updated
1 May 2020
Results posted
No

Publications

  • Falck F Jr, Ricci A Jr, Wolff MS, Godbold J, Deckers P. Pesticides and polychlorinated biphenyl residues in human breast lipids and their relation to breast cancer. Arch Environ Health. 1992 Mar-Apr;47(2):143-6.

    PubMed 1567239
  • Kreiss K, Zack MM, Kimbrough RD, Needham LL, Smrek AL, Jones BT. Cross-sectional study of a community with exceptional exposure to DDT. JAMA. 1981 May 15;245(19):1926-30.

    PubMed 6971946
  • Krieger N, Wolff MS, Hiatt RA, Rivera M, Vogelman J, Orentreich N. Breast cancer and serum organochlorines: a prospective study among white, black, and Asian women. J Natl Cancer Inst. 1994 Apr 20;86(8):589-99. doi: 10.1093/jnci/86.8.589.

    PubMed 8145274

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DDT & DDE pesticide levels in blood (time frame: 10 years +). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00341315, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.

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