- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer
Tidsram: Up to 5 years
|
Up to 5 years
|
Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors
Tidsram: 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
Tidsram: Up to 5 years
|
Up to 5 years
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Judith S. Kaur, MD, Mayo Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCCTG-97-95-51
- NCCTG-979551
- CDR0000078596 (Registeridentifierare: PDQ (Physician Data Query))
- NCI-2013-00323 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
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