Biomarkers in Native American Women With Breast Cancer

NCT00898976 | Completed

• 4 other identifiers: NCCTG-97-95-51NCCTG-979551CDR0000078596NCI-2013-00323
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

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

  Up to 5 years

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

  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

  Up to 5 years

Study Arms (1)

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

immunohistochemistry staining method OTHER

Group I

laboratory biomarker analysis OTHER

Group I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

tissue samples

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Inflammatory Breast Neoplasms

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Judith S. Kaur, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: August 1, 1998
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: July 13, 2016

Record last verified: 2016-07