NCT00341315

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

15.9 years

First QC Date

June 19, 2006

Last Update Submit

April 30, 2020

Conditions

Breast Cancer

Keywords

EpidemiologyDDTBMISerumCase-Control Study

Outcome Measures

Primary Outcomes (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.

    10 years +

Secondary Outcomes (1)

  • Mammogram

    10 years +

Study Arms (1)

Cohort

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

Eligibility Criteria

Age35 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (3)

  • 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.

    PMID: 1567239BACKGROUND

  • 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.

    PMID: 6971946BACKGROUND

  • 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.

    PMID: 8145274BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert N Hoover, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

May 17, 2004

Primary Completion

April 18, 2020

Study Completion

April 30, 2020

Last Updated

May 1, 2020

Record last verified: 2020-04

Locations

US(1)