- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00837499
Breast Cancers: Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.
Comparative Study of Breast Cancers and Their Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Arizona
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Tucson, Arizona, Forenede Stater, 85724-5024
- Arizona Cancer Center
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Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
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Houston, Texas, Forenede Stater, 77030
- LBJ Hospital
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Houston, Texas, Forenede Stater, 77034
- The Rose Diagnostic Center
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Ciudad Obregon, Mexico
- Instituto Tecnologico
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Guadalajara, Mexico
- University of Guadalajara
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Sonora
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Hermosillo, Sonora, Mexico
- University of Sonora
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Male gender
- Inadequate tissue obtained for the four main clinical markers (ER, PR, Her-2/neu and Ki67).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Mexican Women from Mexico
|
Interview and survey during visit or by phone, 30 - 40 minutes.
Andre navne:
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Mexican-American Women in U.S.
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Interview and survey during visit or by phone, 30 - 40 minutes.
Andre navne:
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African-American Women in U.S.
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Interview and survey during visit or by phone, 30 - 40 minutes.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Categorical Response Variables
Tidsramme: 5 years
|
5 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Expression of a breast tumor phenotype marker (expressed versus not expressed)
Tidsramme: 5 Years
|
5 Years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2006-0551
- 3P50CA116199-02S1 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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