Breast CancerNCT00898131
Collecting Tissue Samples for Future Research From Women Undergoing Surgery for Breast Cancer
An observational study of Breast Cancer, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: Collecting and storing samples of tumor tissue from patients with breast cancer to study in the laboratory may help doctors learn more about cancer. PURPOSE: This phase I study is collecting tissue samples for future research from women undergoing surgery for breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Jan 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of breast cancer.
DISEASE CHARACTERISTICS:
- Undergoing surgery for breast cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Clinical Trials Office - Robert H. Lurie Comprehensive Cancer, 312-695-1301, cancer@northwestern.edu
About this study
Official title: Specialized Program of Research Excellence (SPORE) in Breast Cancer: Tissue and Specimen Collection
RATIONALE: Collecting and storing samples of tumor tissue from patients with breast cancer to study in the laboratory may help doctors learn more about cancer.
PURPOSE: This phase I study is collecting tissue samples for future research from women undergoing surgery for breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Collect breast tissue for future research from women undergoing surgery for breast cancer.
Secondary
- Create microarrays by tumor type for internal use by Specialized Program of Research Excellence.
OUTLINE: Tumor tissue is collected and analyzed to create microarrays by tumor type for future research studies.
PROJECTED ACCRUAL: A total of 1,250 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect human breast tissues and associated clinical-pathologic data
Measured: At time of diagnosis, surgery, and throughout standard care and clinical follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 2001
- Primary completionJan 2026 (estimated)
- Study completionJan 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 Northwestern UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Piotr Kulesza, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898131
- Sponsor's protocol ID
- NCI 01X1
- Other IDs
- P50CA089018, P30CA060553, NU-NCI-01X1, NCI-01X1, STU00023488
- Status last verified
- Oct 2025
- First submitted
- 9 May 2009
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialized Program of Research Excellence (SPORE) in Breast Cancer: Tissue and Specimen Collection
- ClinicalTrials.gov ID
- NCT00898131
- Acronym / sponsor ID
- NCI 01X1
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2001
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 May 2009 (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.
RATIONALE: Collecting and storing samples of tumor tissue from patients with breast cancer to study in the laboratory may help doctors learn more about cancer.
PURPOSE: This phase I study is collecting tissue samples for future research from women undergoing surgery for breast cancer.
Detailed description
OBJECTIVES:
Primary
- Collect breast tissue for future research from women undergoing surgery for breast cancer.
Secondary
- Create microarrays by tumor type for internal use by Specialized Program of Research Excellence.
OUTLINE: Tumor tissue is collected and analyzed to create microarrays by tumor type for future research studies.
PROJECTED ACCRUAL: A total of 1,250 patients will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of breast cancer.
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
Collect human breast tissues and associated clinical-pathologic data
Time frame: At time of diagnosis, surgery, and throughout standard care and clinical follow-up.
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 20 Oct 2025.
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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.
Piotr Kulesza, MD, PhD principal investigator
Northwestern University
1 site 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 Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Seema Khan, MD (312-695-1301, cancertrials@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect human breast tissues and associated clinical-pathologic data (time frame: At time of diagnosis, surgery, and throughout standard care and clinical follow-up.). 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 20 Oct 2025.