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CompletedNCT00898976Updated Jul 13, 2016

Biomarkers in Native American Women With Breast Cancer

An observational study in Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by Alliance for Clinical Trials in Oncology · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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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
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 120 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Other: immunohistochemistry staining method · Other: laboratory biomarker analysis

Interventions

  • Otherimmunohistochemistry staining method
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  1. Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer

    Time frame: Up to 5 years

  2. Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors

    Time frame: Up to 5 years

  3. 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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00898976
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Aug 1998
Primary completion
May 2007
Completion
May 2007
Last update
Jul 13, 2016

Study contacts

Judith S. Kaur, MD
study chair · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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