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Biomarkers in Native American Women With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898976
First Posted: May 12, 2009
Last Update Posted: July 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
May 9, 2009
May 12, 2009
July 13, 2016
August 1998
May 2007   (Final data collection date for primary outcome measure)
  • Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer [ Time Frame: Up to 5 years ]
  • Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors [ Time Frame: 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 [ Time Frame: Up to 5 years ]
  • Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer
  • Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors
  • 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
Complete list of historical versions of study NCT00898976 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
tissue samples
Non-Probability Sample
Native American women with primary adenocarcinoma of the breast with 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.
Breast Cancer
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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.
Interventions:
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2007
May 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00898976
NCCTG-97-95-51
NCCTG-979551
CDR0000078596 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2013-00323 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Judith S. Kaur, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2016