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Comparative Study of Breast Cancers and Their Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Comparative Study of Breast Cancers and Their Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.


An epidemiologic study looks at the patterns, causes, and control of disease in groups of
people. Researchers want to see if various risk factors (such as decreased and delayed
fertility, obesity, and a sedentary [low physical activity] lifestyle) and certain markers
that cause breast cancer are different in women in the above groups.

If you have breast cancer and you agree to take part in this study, you will be interviewed
by a trained interviewer with a questionnaire at a time convenient for you, either during
your visit to MD Anderson or The Rose, or by phone. You will be asked questions about your
personal demographics (such as your age and race), environmental exposures, medical history,
family history of cancer, and other day-to-day lifestyle factors. It should take about 30-40
minutes to complete the interview. Clinical data about your breast cancer treatment will
also be collected from your medical records.

You will also have a one-time blood draw (about 3 tablespoons). If blood cannot be drawn or
not enough blood can be drawn, you will have a saliva sample taken where you will be
required to spit into a container. If you have already donated blood or a saliva sample in
the Mexican-American Cohort Study, a portion of that sample may be used instead of having to
collect a new sample. Your blood or saliva sample will be used to look at your DNA (genetic
material of cells). The study pathologist will look at possible prognostic markers
(substances that predict outcome of disease) from tissue obtained from your surgery.

Neither you nor your regular doctor will receive reports of this research study. The results
of this research study will not be placed in your health records. All of your information
obtained in this study will be kept confidential either in a password-protected computer or
in a locked file cabinet in a secure location.

Your participation will be over in this study when all the data has been collected and
analyzed.

This is an investigational study. Up to 1,825 women will take part in this multicenter
study. Up to 1125 will be enrolled at MD Anderson.


Inclusion Criteria:



1. All women of Mexican and African descent ages 18 years or older.

2. Diagnosis of invasive breast cancer (histologically confirmed invasive
adenocarcinoma, including ductal, lobular, medullary, tubular and mucinous cellular
patterns) within the past 24 months.

3. Willing to complete a questionnaire.

4. Consent to tissue acquisition (remaining after surgery or preoperative core needle
biopsy).

Exclusion Criteria:

1. Male gender

2. Inadequate tissue obtained for the four main clinical markers (ER, PR, Her-2/neu and
Ki67).

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Categorical Response Variables

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Abenaa M. Brewster, MD, MHS, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0551

NCT ID:

NCT00837499

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast
  • Breast Cancer
  • Risk Factors
  • Mexican Women
  • Mexican-American Women
  • African-American Women
  • Epidemiological
  • Questionnaire
  • Survey
  • Interview
  • Breast Neoplasms

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
UT MD Anderson Cancer Center Houston, Texas  77030
LBJ Hospital Houston, Texas  77030
The Rose Diagnostic Center Houston, Texas  77034