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Breast Cancer, Breast Disease, and Pesticides

2020年4月30日 更新者:National Cancer Institute (NCI)

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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

228

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Alabama
      • Birmingham、Alabama、アメリカ、35233
        • University of Alabama

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

35年~80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

  • INCLUSION CRITERIA:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
Cohort
A primarily African-American population living in the vicinity of a DDT production plant inAlabama.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
DDT & DDE pesticide levels in blood
時間枠:10 years +
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.
10 years +

二次結果の測定

結果測定
時間枠
Mammogram
時間枠:10 years +
10 years +

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Robert N Hoover, M.D.、National Cancer Institute (NCI)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2004年5月17日

一次修了 (実際)

2020年4月18日

研究の完了 (実際)

2020年4月30日

試験登録日

最初に提出

2006年6月19日

QC基準を満たした最初の提出物

2006年6月19日

最初の投稿 (見積もり)

2006年6月21日

学習記録の更新

投稿された最後の更新 (実際)

2020年5月1日

QC基準を満たした最後の更新が送信されました

2020年4月30日

最終確認日

2020年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 999904196
  • 04-C-N196

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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