Clinical trial NCT00588029: Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer
Official title: Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Family members
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Memorial University Medical Center
First posted: 2008-01-08
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients seen at Memorial Sloan-Kettering Cancer Center

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: None. This is a tissue banking study.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark Robson, MD
role: PRINCIPAL_INVESTIGATOR
References: