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 April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Memorial University Medical Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588029
First received: December 24, 2007
Last updated: April 3, 2014
Last verified: April 2014
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer

Resource links provided by NLM:


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

Blood, Cerebro-Spinal Fluid and Saliva


Estimated Enrollment: 7000
Study Start Date: July 1999
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
breast cancer patients
2
control subjects without breast cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
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:

  • For acquisition of existing breast cancer tissue specimens from the MSKCC Tissue Procurement Service, the only criteria are a pathologically-confirmed diagnosis of invasive breast cancer and the availability of corresponding nonmalignant tissue from each case.
  • For the prospective acquisition of blood or saliva from control subjects without breast cancer, eligibility criteria include:
  • 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 female patient, or any female over the age of 18 accompanying a patient under the care of a physician in the Department of Urology, Department of Surgery, or Department of Medicine.
  • Subjects will have no history of preinvasive (carcinoma in situ) or invasive breast cancer.
  • Subjects will be eligible without regard to racial, or ethnic status. Attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., mentally impaired) reasons.
  • For the prospective acquisition of blood, saliva, pleural fluid or cerebrospinal fluid from patients who have or are suspected of having breast cancer or carcinoma in-situ, eligibility criteria include:
  • Any patient 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.
  • All subjects must be under the care of one or more members of the MSKCC Breast Disease Management Team at the time of enrollment.
  • Subjects may have received prior hormonal therapy, cytotoxic chemotherapy, radiation therapy, or surgical therapy at MSKCC or another institution.
  • All subjects must be 18 years or older
  • Subjects will be eligible without regard to sex, racial, or ethnic status. It is anticipated that approximately 99% of the patients will be female. Attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., mentally impaired) reasons.
  • If, after pathologic diagnosis, preinvasive or invasive breast disease is not found, patients previously consented for the blood collection aspect of this protocol will not be included.

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 646-888-5352
Contact: Mark Robson, MD 646-888-4058

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Tari King, MD    646-888-5352      
Principal Investigator: Tari King, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Tari King, MD    646-888-5352      
Principal Investigator: Tari King, MD         
Memorial Sloan-Kettering Cancer Recruiting
New York, New York, United States, 10065
Contact: Tari King, MD    646-888-5352      
Contact: Mark Robson, MD    646-888-4058      
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
ClinicalTrials.gov Identifier: NCT00588029     History of Changes
Other Study ID Numbers: 99-030
Study First Received: December 24, 2007
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014