NCT00898131

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
16.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

24.4 years

First QC Date

May 9, 2009

Last Update Submit

October 15, 2025

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Collect human breast tissues and associated clinical-pathologic data

    At time of diagnosis, surgery, and throughout standard care and clinical follow-up.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

DISEASE CHARACTERISTICS: * Undergoing surgery for breast cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue from diagnostic biopsies, as well as initial or follow-up surgical procedures for the treatment or prevention of breast cancer. No extra tissue is taken, only what is left over following clinical use will be retained for banking purposes.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Piotr Kulesza, MD, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seema Khan, MD

CONTACT

312-695-1301cancertrials@northwestern.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

August 1, 2001

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations

US(1)