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Study Summary
No. 2006-0551:.......Breast......Melissa Bondy......Epidemiology
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Study Summary Title
Study Summary
Number:
2006-0551
Study 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.
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Physician New Patient Referral
Name:Melissa BondyPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:EpidemiologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-5264
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:N/A
Phase of Study:N/AReturn
Visit:
N/A
Treatment
Agents:
NoneHome Care:N/A
Treatment Loc:MDACC + Community Programs (CCOP/Network)
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
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.
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Study Objectives / Outcomes
The proposed feasibility study is to determine our ability to conduct an international multicentered collaboration. The study will investigate whether epidemiological and clinical risk factors as well as standard and novel tumor markers which predict for increased incidence and prognosis of breast cancer differ, between women in Mexico and Mexican-American women living in the United States (US).
Primary Aims
1. To compare profiles of tumor markers of prognostic and/or predictive importance (ER, PR, HER-2/neu, Ki67) and more novel tumor markers (cyclin D, cyclin E, p27, PTEN, GATA-3, TRPS1, APTá) between women in Mexico and Mexican-American living in the US.
2. To assess whether differences in markers are more pronounced in postmenopausal women compared to premenopausal women and whether these are explained by factors associated with acquisition of lifestyles more representative of the US (low parity, late age at first birth, adult weight gain pattern, and body composition (waist circumference and body mass index).

In addition to our primary aims, we propose 3 secondary aims: 1) in the Houston area only (at M. D. Anderson, LBJ Hospital and the Rose Clinic) we will compare breast cancer risk factors and standard and novel tumor markers between Mexican-American and African American women and conduct descriptive statistics; 2) to evaluate the prevalence of no more than 500,000 polymorphic sites in parafin embedded and fresh frozen tumor samples using high density SNP arrays. We will explore whether there are differences in tumor chromosomal changes between women in Mexico and Mexican American living in the US; 3) to develop a platform to determine the genetic admixture of women in Mexico and Mexican-Americans using whole blood or saliva cell derived germline DNA. The level of population mixing of European and indigenous American ancestry will be correlated with the panel of standard tumor markers and the patterns of chromosomal aberrations observed in the tumor samples.
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Study Status Information
Study Activation / Registration Date:01/26/2007
IRB Review and Approval Date:11/30/2006
Study Type:Other
Recruitment Status:Open
Projected Accrual:1825
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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).

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Links
Registration Number: NCT00837499
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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