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

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 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

Name: Seema Khan, MD
Phone Number: 312-695-1301
Email: cancertrials@northwestern.edu

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

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