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

This study is currently recruiting participants.
Verified November 2016 by Northwestern University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898131
First Posted: May 12, 2009
Last Update Posted: November 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
  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:


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:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
Criteria

DISEASE CHARACTERISTICS:

  • Undergoing surgery for breast cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00898131     History of Changes
Other Study ID Numbers: NCI 01X1
P50CA089018 ( U.S. NIH Grant/Contract )
P30CA060553 ( U.S. NIH Grant/Contract )
NU-NCI-01X1
NCI-01X1
STU00023488 ( Other Identifier: Northwestern University IRB# )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: November 17, 2016
Last Verified: November 2016

Keywords provided by Northwestern University:
breast cancer

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