Molecular Analysis of Breast Cancer

NCT ID: NCT00569049

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

788 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-05-31

Study Completion Date

2011-07-01

Brief Summary

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This is a research-based study that is looking at the biologic features of breast tissue, lymph node tissue, or blood in order to study breast cancer development growth, and spread. Through tissue and/or blood samples we hope to gain further knowledge and understanding of how to improve diagnosis and treatment of breast cancer by identifying the molecular markers that predict clinical outcome and response to therapy.

Detailed Description

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The tissue obtained in this protocol will be used for genome-wide examination of DNA, RNA expression profiling, proteomic analyses, isolation and analyses of normal and cancer stem cells, isolation and analyses of circulating tumor cells, possible analyses of immune cells, and possible analyses of serum factors. The tissue may also be used to develop patient-specific cell culture models or mouse xenograft models of breast cancer for biologic study of tumor progression and metastases and for therapeutic testing. In general, the tissue will be used in studies that will molecularly classify tumors, identify prognostic markers, identify potential therapeutic markers, identify potential treatment targets, and help us better understand the biology and specific role played by different tumor cells in the metastatic process.

The ultimate goal is to use molecular analyses to improve the diagnosis and treatment of breast cancer.

Conditions

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Breast Cancer Breast Cancer Non-invasive Breast Cancer Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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breast tissue, lymph node tissue or blood

Molecular Analyses of samples

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:People eligible for this study include anyone older than 18 years who is undergoing one of the following procedures: core needle or surgical breast biopsy, lumpectomy, mastectomy, axillary lymph node surgery, breast reduction surgery, or ductal lavage or ductoscopy. Patients who have had breast cancer in the past who are currently free of disease or who have a breast cancer recurrence are also eligible. All patients who participate must be able to understand and sign the informed consent. Although most patients will be female, any males undergoing the above procedures are also eligible for this study.

Exclusion Criteria

Exclusion Criteria:Any patient who is less than 18 years old, who is unable to understand the informed consent, or not undergoing the above procedures will be excluded from this research.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of California

OTHER

Sponsor Role collaborator

California Breast Cancer Research Program

OTHER

Sponsor Role collaborator

Breast Cancer Research Foundation

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Curtis, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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1028313-100-JAACC

Identifier Type: -

Identifier Source: secondary_id

1045090-101-KBAHQ

Identifier Type: -

Identifier Source: secondary_id

10EB-10086; 11IB-0175

Identifier Type: -

Identifier Source: secondary_id

CA085129; 1R01CA109325-01

Identifier Type: -

Identifier Source: secondary_id

8EB-1106

Identifier Type: -

Identifier Source: secondary_id

BRSNSTU0001

Identifier Type: OTHER

Identifier Source: secondary_id

SU-11052007-799

Identifier Type: -

Identifier Source: org_study_id

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