Collecting Tissue Samples for Future Research From Women Undergoing Surgery for Breast Cancer

October 15, 2025 updated by: Northwestern University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Recruiting
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
        • Contact:
          • Clinical Trials Office - Robert H. Lurie Comprehensive Cancer
          • Phone Number: 312-695-1301
          • Email: cancer@northwestern.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of breast cancer.

Description

DISEASE CHARACTERISTICS:

  • Undergoing surgery for breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collect human breast tissues and associated clinical-pathologic data
Time Frame: At time of diagnosis, surgery, and throughout standard care and clinical follow-up.
At time of diagnosis, surgery, and throughout standard care and clinical follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Piotr Kulesza, MD, PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimated)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 15, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI 01X1
  • P30CA060553 (U.S. NIH Grant/Contract)
  • P50CA089018 (U.S. NIH Grant/Contract)
  • NU-NCI-01X1
  • NCI-01X1
  • STU00023488 (Other Identifier: Northwestern University IRB#)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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