Biomarkers in Native American Women With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898976
First received: May 9, 2009
Last updated: May 16, 2009
Last verified: May 2007

May 9, 2009
May 16, 2009
August 1998
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  • Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer [ Designated as safety issue: No ]
  • Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Same as current
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.

PROJECTED ACCRUAL: A total of 300 tissue samples (150 from Native American women and 150 from Caucasian women) will be accrued for this study.

Observational
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Breast Cancer
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
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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
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00898976
CDR0000078596, NCCTG-979551
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Judith S. Kaur, MD Mayo Clinic
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP