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Active, not recruitingNCT00569049Updated Feb 24, 2023

Molecular Analysis of Breast Cancer

An observational study in Breast Cancer, Breast Cancer Non-invasive Breast Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Stanford University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-24.

Sponsored by Stanford University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
99,999
Ages
18 Years and older
Sex
Female
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Study summary

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.

Read the detailed description

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.

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Conditions studied

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

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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 planned enrollment of 99,999 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) 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
Yes
Sampling method
Non-probability sample

Study population

patients undergoing breast cancer procedures

Eligibility 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: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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
99,999 participants (estimated)
Biospecimen retention
Samples with dna

Interventions

  • Procedurebreast tissue, lymph node tissue or blood

    Molecular Analyses of samples

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Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2023, 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
NCT00569049
Lead sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), University of California, California Breast Cancer Research Program, Breast Cancer Research Foundation
Responsible party
Sponsor
First posted
Dec 6, 2007
Start date
May 1996
Primary completion
May 2050 (estimated)
Completion
May 2050 (estimated)
Last update
Feb 24, 2023

Study contacts

Stefanie S. Jeffrey M.D.
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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