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Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161265
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

Condition or disease Intervention/treatment
Breast Cancer Procedure: tissue procurement

Detailed Description:
This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: UMCC 2004.064: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer
Study Start Date : May 2005
Actual Primary Completion Date : August 2012
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
1
women with breast cancer
Procedure: tissue procurement
tissue procurement




Biospecimen Retention:   Samples Without DNA
tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women with breast cancer
Criteria

Inclusion Criteria:

  1. All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible.
  2. The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast.
  3. The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy.
  4. Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
  5. All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards.

    -

Exclusion Criteria:

  1. Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
  2. Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
  3. Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
  4. Patients with another active systemic malignancy in the past year.

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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): NCT00161265


Locations
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United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Anne F. Schott, M.D. University of Michigan Rogel Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00161265    
Other Study ID Numbers: UMCC 2004.064
IRB # 2005-009 and HUM 44194 ( Other Identifier: University of Michigan Medical IRB )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases