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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00837499
First received: February 4, 2009
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparative Study of Breast Cancers and Their Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Categorical Response Variables [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expression of a breast tumor phenotype marker (expressed versus not expressed) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

One-time blood draw (about 3 tablespoons). If blood cannot be drawn or not enough blood can be drawn, a saliva sample will be taken.


Estimated Enrollment: 1825
Study Start Date: September 2008
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mexican Women from Mexico Behavioral: Questionnaire
Interview and survey during visit or by phone, 30 - 40 minutes.
Other Name: Survey
Mexican-American Women in U.S. Behavioral: Questionnaire
Interview and survey during visit or by phone, 30 - 40 minutes.
Other Name: Survey
African-American Women in U.S. Behavioral: Questionnaire
Interview and survey during visit or by phone, 30 - 40 minutes.
Other Name: Survey

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Woman, 18 years or older, of Mexican descent (Mexican or Mexican-American) or an African-American woman, and have invasive breast cancer during past 12 months.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837499

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
United States, Texas
LBJ Hospital
Houston, Texas, United States, 77030
The Rose Diagnostic Center
Houston, Texas, United States, 77034
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Mexico
University of Sonora
Hermosillo, Sonora, Mexico
Instituto Tecnologico
Ciudad Obregon, Mexico
University of Guadalajara
Guadalajara, Mexico
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Abenaa M. Brewster, MD, MHS, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00837499     History of Changes
Other Study ID Numbers: 2006-0551
Study First Received: February 4, 2009
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast
Breast Cancer
Risk Factors
Mexican Women
Mexican-American Women
African-American Women
Epidemiological
Questionnaire
Survey
Interview

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014