We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00837499
Recruitment Status : Recruiting
First Posted : February 5, 2009
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Questionnaire

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.


Study Design

Study Type : Observational
Estimated Enrollment : 1825 participants
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.
Actual Study Start Date : September 2008
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Categorical Response Variables [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Expression of a breast tumor phenotype marker (expressed versus not expressed) [ Time Frame: 5 Years ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837499


Contacts
Contact: Abenaa M. Brewster, MD, MHS, BS 713-745-4928

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00837499     History of Changes
Other Study ID Numbers: 2006-0551
3P50CA116199-02S1 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases