10,000 breast cancer patients to donate samples for future research
NCT ID NCT01000883
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study collects tumor tissue and blood samples from 10,000 women with breast cancer to build a large biorepository. Researchers will analyze these samples to find molecular markers that may predict how well a patient responds to therapy. The goal is to better understand breast cancer behavior and improve future treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors identify biomarkers that predict how breast cancer patients respond to therapy, potentially guiding more personalized treatment in the future.
- What could go wrong
- This is an observational study focused on sample collection, not a treatment trial. It may not directly lead to new therapies, and results depend on future research using the samples.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 10,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 1998
- Expected to finish
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Nov 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants will be selected from those individuals receiving diagnostic and treatment related biopsies at the University of North Carolina at Chapel Hill.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: High suspicion of or known breast cancer (early or metastatic) Lesion accessible for safe biopsy (as deemed by the treating physician). Age ≥ 18 years. ECOG performance status 0 - 2. Ability to understand and willingness to sign an informed consent document. If receiving therapeutic anticoagulation; it should be discontinued temporarily prior to biopsy for a length of time to be determined by the study doctor. Adequate marrow function, defined as absolute neutrophil count ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L required only for biopsies of vital organs (lung, liver, etc.) Exclusion Criteria: Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) Pregnant women are excluded because there may be an increased risk to both mother and fetus in the setting of conscious sedation, which is required for biopsies of certain anatomic sites (e.g. liver, lung). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus. Cardiac disease making it unsafe to biopsy in the opinion of the treating physician. If patients receiving bevacizumab or other angiogenesis inhibitors are less than 6 weeks from last dose of the angiogenesis inhibitor, they should not undergo research core biopsies of vital organs (lung, liver, etc.) on this protocol because of the concern for the possibility of increased bleeding risk and delayed healing. Patients receiving bevacizumab or other angiogenesis inhibitors who are undergoing a research biopsy of the breast, peripheral lymph node or a skin punch biopsy must be two weeks from the last dose of the angiogenesis inhibitor.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27599-7295, United States
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