Tuesday, January 31, 2006

MMRC ancillary tissue collection project

Multiple Myeloma Research Consortium (MMRC) Ancillary Tissue Collection Project

Purpose

The MMRC Tissue Bank is collecting blood and bone marrow samples and correlating clinical data from patients with multiple myeloma at the time of their blood or marrow donations for clinical care. The collection of these samples will be critical to support ongoing research projects in the area of tumor genomics and in general for tumor biology. These samples will be collected, processed and stored in a way that will allow their future use in multiple research projects and may be shared in the future with outside investigators (researchers outside of the Consortium). The samples will be housed at the MMRC Tissue Bank currently located at Mayo Clinic Scottsdale, Arizona and will be stored indefinitely.

Regimen

Patients diagnosed with multiple myeloma with any stage of disease regardless of the number or type(s) of prior treatments may participate in this tissue collection study. Samples will be collected at the clinic only after informed consent has been voluntarily given by the study participant. At the time of routine clinical procurement the physician will collect up to 40 cc of extra bone marrow aspirate and up to 50 cc of peripheral blood. The study participant’s medical record will be reviewed prior to blood draw and participants with hemoglobin that is less than 7g/dl will be excluded from this collection. Study participants may donate a sample to the MMRC Tissue Bank with each clinically necessary bone marrow aspirate procurement.

Study participants will be assigned a unique identification number so that only the physician and his/her staff at the enrolling institution will be able to link the unique identification number to the participant’s identifiable information.

Once the study participant donates a sample to the MMRC Tissue Bank, the physician or his/her staff at the clinic will code the sample with a unique sample number so as not to identify the study participant. This number is different than the number the participant is assigned as explained above. This number is also different for each time a participant donates a sample. This code will allow the sample to be used without anyone knowing that it is the participant’s sample just by looking at the label. Only the physician or his/her staff at the clinic will be able to link the sample’s unique identification number to the participant’s name.

These identifiers will allow for the retrospective linking of a sample to the medical record such that we can perform the appropriate clinical correlations and annotations. The list with these links will be kept in a locked secured place at the clinic and all transfer of information will be done consistent with current HIPAA guidelines for participants’ privacy and protection.

Arizona
Scottsdale, AZ
Mayo Clinic -
Scottsdale

Florida
Tampa, FL
H. Lee Moffitt Cancer Center & Research Institute

Minnesota
Rochester, MN
Mayo Clinic -
Rochester

Massachusetts
Boston, MA
Dana-Farber Cancer Institute

Canada
Toronto, ON
Princess Margaret Hospital

Source: http://multiplemyeloma.org/clinical_trials/ctm/4.04.209.html

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