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

This study is currently recruiting participants.
Verified May 2013 by Northwestern University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00898131
First received: May 9, 2009
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

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:

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.

  Eligibility

Genders 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.

Criteria

DISEASE CHARACTERISTICS:

  • Undergoing surgery for breast cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898131

Contacts
Contact: Seema Khan, MD 312-695-1301 cancertrials@northwestern.edu

Locations
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     cancer@northwestern.edu    
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Piotr Kulesza, MD, PhD Northwestern University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00898131     History of Changes
Other Study ID Numbers: NCI 01X1, P50CA089018, P30CA060553, NU-NCI-01X1, NCI-01X1, STU00023488
Study First Received: May 9, 2009
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013