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Biomarkers in Native American Women With Breast Cancer

Molecular Markers in Native American Women With Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00898976
Enrollment
120
Registered
2009-05-12
Start date
1998-08-31
Completion date
2007-05-31
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, breast cancer in situ, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer, stage IIIC breast cancer

Brief summary

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.

Detailed description

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.

Interventions

OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 RegistryUp to 5 years
Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancerUp to 5 years
Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factorsUp to 5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026