Biomarkers in Native American Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898976
First received: May 9, 2009
Last updated: July 12, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention
Breast Cancer
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Markers in Native American Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors [ Time Frame: Up to 5 years ] [ 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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
tissue samples

Enrollment: 120
Study Start Date: August 1998
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898976

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Judith S. Kaur, MD Mayo Clinic
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00898976     History of Changes
Other Study ID Numbers: NCCTG-97-95-51  NCCTG-979551  CDR0000078596  NCI-2013-00323 
Study First Received: May 9, 2009
Last Updated: July 12, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 29, 2016