- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00898976
Biomarkers in Native American Women With Breast Cancer
Molecular Markers in Native American Women With Breast Cancer
RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients.
PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Evaluate a selected panel of molecular markers in tissue specimens from Native American women with breast cancer.
- Determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients.
- Compare and contrast the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry.
OUTLINE: Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
DISEASE CHARACTERISTICS:
- Diagnosis of primary adenocarcinoma of the breast in Native American women
Prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000
- Paraffin-embedded tissue available
- Paraffin-embedded tissue available from Caucasian women with breast cancer enrolled on NCCTG-77-30-51 or the Mayo Breast Cancer Registry
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Group I
Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.
PROJECTED ACCRUAL: A total of 300 tissue samples (150 from Native American women and 150 from Caucasian women) will be accrued for this study.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer
Tidsramme: Up to 5 years
|
Up to 5 years
|
Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors
Tidsramme: Up to 5 years
|
Up to 5 years
|
Comparison of the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry
Tidsramme: Up to 5 years
|
Up to 5 years
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Judith S. Kaur, MD, Mayo Clinic
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCCTG-97-95-51
- NCCTG-979551
- CDR0000078596 (Registeridentifikator: PDQ (Physician Data Query))
- NCI-2013-00323 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
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