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

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Northwestern University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University Identifier:
First received: May 9, 2009
Last updated: November 16, 2016
Last verified: November 2016

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.

Condition Phase
Breast Cancer Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specialized Program of Research Excellence (SPORE) in Breast Cancer: Tissue and Specimen Collection

Resource links provided by NLM:

Further study details as provided by Northwestern University:

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

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.

Estimated Enrollment: 10000
Study Start Date: August 2001
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Detailed Description:



  • Collect breast tissue for future research from women undergoing surgery for breast cancer.


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
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.


  • Undergoing surgery for breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00898131

Contact: Seema Khan, MD 312-695-1301

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301   
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: Piotr Kulesza, MD, PhD Northwestern University
  More Information

Responsible Party: Northwestern University Identifier: NCT00898131     History of Changes
Other Study ID Numbers: NCI 01X1
P50CA089018 ( U.S. NIH Grant/Contract )
P30CA060553 ( U.S. NIH Grant/Contract )
STU00023488 ( Other Identifier: Northwestern University IRB# )
Study First Received: May 9, 2009
Last Updated: November 16, 2016

Keywords provided by Northwestern University:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on August 17, 2017