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. (see Contacts and Locations)
Verified July 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: July 17, 2014
Last verified: July 2014

December 24, 2007
July 17, 2014
July 1999
December 2015   (final data collection date for primary outcome measure)
None. This is a tissue banking study. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00588029 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer
Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood, Cerebro-Spinal Fluid and Saliva

Non-Probability Sample

Breast cancer patients seen at Memorial Sloan-Kettering Cancer Center

Breast Cancer
Not Provided
  • 1
    breast cancer patients
  • 2
    control subjects without breast cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
7000
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Tari King, MD 646-888-5352
Contact: Mark Robson, MD 646-888-4058
United States
 
NCT00588029
99-030
No
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Memorial University Medical Center
Principal Investigator: Tari King, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP