Breast CancerNCT00588029
Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
The purpose of this study is to collect a blood sample from patients with breast disease (cases) and from individuals without breast cancer (controls)that may be used for research purposes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 7,000 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 1999to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients seen at Memorial Sloan-Kettering Cancer Center
Who may be able to join
- For acquisition of existing breast cancer tissue specimens from the MSKCC Tissue Procurement Service, the only criteria are a pathologically-confirmed diagnosis of invasive breast cancer and the availability of corresponding nonmalignant tissue from each case.
- For the prospective acquisition of blood or saliva from control subjects without breast cancer, eligibility criteria include:
- Any patient with a previous diagnosis of invasive breast cancer who undergoes a palliative procedure related to the presence of a pleural effusion is eligible for the pleural fluid collection aspect of this protocol.
- Any female patient, or any female over the age of 18 accompanying a patient under the care of a physician in the Department of Urology, Department of Surgery, or Department of Medicine.
- Subjects will have no history of preinvasive (carcinoma in situ) or invasive breast cancer.
- Subjects will be eligible without regard to racial, or ethnic status. Attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., mentally impaired) reasons.
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- For the prospective acquisition of blood, saliva, pleural fluid or cerebrospinal fluid from patients who have or are suspected of having breast cancer or carcinoma in-situ, eligibility criteria include:
- Any patient at MSKCC with a previously confirmed or suspected diagnosis of malignant or premalignant (e.g., carcinoma in situ) breast disease is eligible for inclusion in the blood acquisition aspect of this protocol.
- Any patient with a previous diagnosis of invasive breast cancer who undergoes a palliative procedure related to the presence of a pleural effusion is eligible for the pleural fluid collection aspect of this protocol.
- Any patient with a previous diagnosis of invasive breast cancer with leptomeningeal metastasis who undergoes a routine procedure associated with the collection of cerebrospinal fluid is eligible for the cerebrospinal fluid collection aspect of this protocol.
- All subjects must be under the care of one or more members of the MSKCC Breast Disease Management Team at the time of enrollment.
- Subjects may have received prior hormonal therapy, cytotoxic chemotherapy, radiation therapy, or surgical therapy at MSKCC or another institution.
- All subjects must be 18 years or older
- Subjects will be eligible without regard to sex, racial, or ethnic status. It is anticipated that approximately 99% of the patients will be female. Attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., mentally impaired) reasons.
- If, after pathologic diagnosis, preinvasive or invasive breast disease is not found, patients previously consented for the blood collection aspect of this protocol will not be included.
Who cannot join
- For the prospective acquisition of blood or saliva from control subjects without breast cancer, ineligibility criteria include:
- A first degree relative (mother, daughter, sister, father, brother or son) who has been diagnosed with breast cancer.
- A personal history of breast cancer, lobular carcinoma in situ or atypia.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan-Kettering Cancer
New York, New York, 10065
About this study
The purpose of this study is to collect a blood sample from patients with breast disease (cases) and from individuals without breast cancer (controls)that may be used for research purposes. These blood samples will be used by researchers at Memorial Sloan-Kettering Cancer Center who study the causes of breast cancer, as well as more effective ways to prevent, diagnose, and treat breast cancer.
- Conditions
- Breast Cancer
- Keywords
- Family members
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | breast cancer patients | |
| 2 | control subjects without breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
None. This is a tissue banking study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startJul 1999
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial University Medical Center
- Responsible party
- Sponsor
- Investigators
- Mark Robson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588029
- Sponsor's protocol ID
- 99-030
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2007
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT00588029
- Acronym / sponsor ID
- 99-030
- Conditions
- Breast Cancer
- Keywords
- Family members
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Memorial University Medical Center
- Study start
- Jul 1999
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect a blood sample from patients with breast disease (cases) and from individuals without breast cancer (controls)that may be used for research purposes. These blood samples will be used by researchers at Memorial Sloan-Kettering Cancer Center who study the causes of breast cancer, as well as more effective ways to prevent, diagnose, and treat breast cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –breast cancer patients |
| 2 | – | –control subjects without breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients seen at Memorial Sloan-Kettering Cancer Center
Key inclusion criteria (15 listed)
- For acquisition of existing breast cancer tissue specimens from the MSKCC Tissue Procurement Service, the only criteria are a pathologically-confirmed diagnosis of invasive breast cancer and the availability of corresponding nonmalignant tissue from each case.
- For the prospective acquisition of blood or saliva from control subjects without breast cancer, eligibility criteria include:
- Any patient with a previous diagnosis of invasive breast cancer who undergoes a palliative procedure related to the presence of a pleural effusion is eligible for the pleural fluid collection aspect of this protocol.
- Any female patient, or any female over the age of 18 accompanying a patient under the care of a physician in the Department of Urology, Department of Surgery, or Department of Medicine.
- Subjects will have no history of preinvasive (carcinoma in situ) or invasive breast cancer.
Key exclusion criteria (3 listed)
- For the prospective acquisition of blood or saliva from control subjects without breast cancer, ineligibility criteria include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
None. This is a tissue banking study.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Robson, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
None. This is a tissue banking study. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.