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Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, November 2008
First Received: December 24, 2007   Last Updated: November 11, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
Memorial University Medical Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588029
  Purpose

The purpose of this study is to collect a blood sample from patients with breast disease (cases) and from individuals without breast cancer (controls)that may be used for research purposes. These blood samples will be used by researchers at Memorial Sloan-Kettering Cancer Center who study the causes of breast cancer, as well as more effective ways to prevent, diagnose, and treat breast cancer.


Condition
Breast Cancer

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • None. This is a tissue banking study. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood, Cerebro-Spinal Fluid and Saliva


Estimated Enrollment: 6000
Study Start Date: July 1999
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
breast cancer patients
2
control subjects without breast cancer

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer patients seen at Memorial Sloan-Kettering Cancer Center

Criteria

Inclusion Criteria:

  • Pathologically-confirmed diagnosis of invasive breast cancer and the availability of corresponding nonmalignant tissue from each case.
  • For the prospective acquisition of blood, pleural fluid or cerebrospinal fluid from breast cancer patients, eligibility criteria include:

    • Any patient scheduled for inpatient or outpatient surgery at MSKCC with a previously confirmed or suspected diagnosis of malignant or premalignant (e.g., carcinoma in situ) breast disease is eligible for inclusion in the blood acquisition aspect of this protocol.
    • Any patient with a previous diagnosis of invasive breast cancer who undergoes a palliative procedure related to the presence of a pleural effusion is eligible for the pleural fluid collection aspect of this protocol.
    • Any patient with a previous diagnosis of invasive breast cancer with leptomeningeal metastasis who undergoes a routine procedure associated with the collection of cerebrospinal fluid is eligible for the cerebrospinal fluid collection aspect of this protocol.
    • May have received prior hormonal therapy, cytotoxic chemotherapy, radiation therapy, or surgical therapy at MSKCC or another institution.
  • For the prospective acquisition of blood or saliva from control subjects without breast cancer, eligibility criteria include:

    • Any female patient, or any female accompanying a patient under the care of a physician in the Department of Urology, Department of Surgery, or Department of Medicine, with no history of preinvasive (carcinoma in situ) or invasive breast cancer.

Exclusion Criteria:

  • For the prospective acquisition of blood or saliva from control subjects without breast cancer, ineligibility criteria include:

    • A first degree relative (mother, daughter, sister, father, brother or son) who has been diagnosed with breast cancer.
    • A personal history of breast cancer, lobular carcinoma in situ or atypia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588029

Contacts
Contact: Tari King, MD 212-639-7308 kingt@mskcc.org
Contact: Mark Robson, MD robsonm@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Recruiting
New York, New York, United States, 10065
Contact: Tari King, MD         kingt@mskcc.org    
Contact: Mark Robson, MD         robsonm@mskcc.org    
Principal Investigator: Tari King, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Memorial University Medical Center
Investigators
Principal Investigator: Tari King, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Tari King, MD )
Study ID Numbers: 99-030
Study First Received: December 24, 2007
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00588029     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Family members

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009