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Breast Cancers: Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00837499
Enrollment
938
Registered
2009-02-05
Start date
2007-01-01
Completion date
2021-05-10
Last updated
2021-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

Brief summary

The goal of this epidemiologic research study is to find out if various risk factors and certain markers (substances that help identify the presence of cancer) that help predict increased occurrence and prognosis (outcome of disease) of breast cancer differ among Mexican, Mexican-American, and African-American women.

Detailed description

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.

Interventions

BEHAVIORALQuestionnaire

Interview and survey during visit or by phone, 30 - 40 minutes.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Categorical Response Variables5 years

Secondary

MeasureTime frame
Expression of a breast tumor phenotype marker (expressed versus not expressed)5 Years

Countries

Mexico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026