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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00837499 |
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. |
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 2013 (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
|
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 M. D. 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 M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Abenaa M. Brewster, MD, MHS, BS | 713-745-4928 |
| United States, Arizona | |
| Arizona Cancer Center | Recruiting |
| Tucson, Arizona, United States, 85724-5024 | |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| LBJ Hospital | 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 | |
| Principal Investigator: | Abenaa M. Brewster, MD, MHS, BS | UT MD Anderson Cancer Center |
More Information
| 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: | October 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Breast Breast Cancer Risk Factors Mexican Women Mexican-American Women |
African-American Women Epidemiological Questionnaire Survey Interview |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
