NCT00837499

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
938

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

14.4 years

First QC Date

February 4, 2009

Last Update Submit

May 12, 2021

Conditions

Keywords

BreastBreast CancerRisk FactorsMexican WomenMexican-American WomenAfrican-American WomenEpidemiologicalQuestionnaireSurveyInterview

Outcome Measures

Primary Outcomes (1)

  • Categorical Response Variables

    5 years

Secondary Outcomes (1)

  • Expression of a breast tumor phenotype marker (expressed versus not expressed)

    5 Years

Study Arms (3)

Mexican Women from Mexico

Behavioral: Questionnaire

Mexican-American Women in U.S.

Behavioral: Questionnaire

African-American Women in U.S.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

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

Also known as: Survey
African-American Women in U.S.Mexican Women from MexicoMexican-American Women in U.S.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All women of Mexican and African descent ages 18 years or older.
  • Diagnosis of invasive breast cancer (histologically confirmed invasive adenocarcinoma, including ductal, lobular, medullary, tubular and mucinous cellular patterns) within the past 24 months.
  • Willing to complete a questionnaire.
  • Consent to tissue acquisition (remaining after surgery or preoperative core needle biopsy).

You may not qualify if:

  • Male gender
  • Inadequate tissue obtained for the four main clinical markers (ER, PR, Her-2/neu and Ki67).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Arizona Cancer Center

Tucson, Arizona, 85724-5024, United States

Location

LBJ Hospital

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The Rose Diagnostic Center

Houston, Texas, 77034, United States

Location

University of Sonora

Hermosillo, Sonora, Mexico

Location

Instituto Tecnologico

Ciudad Obregón, Mexico

Location

University of Guadalajara

Guadalajara, Mexico

Location

Related Links

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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Abenaa M. Brewster, MD, MHS, BS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

January 1, 2007

Primary Completion

May 10, 2021

Study Completion

May 10, 2021

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations