Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)
Background: -Patients who are being evaluated and/or treated at the NIH Clinical Centre (pediatric and adult) and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Objectives: - To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. - To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Eligibility: -Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Centre and adult patients from participating sites. Design: - This is a multicentre tissue procurement protocol with NCI as the coordinating centre. - For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumour tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumour cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol. - For pediatric patients: tumour biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits. - Given the risks associated with any invasive procedure, such as tumour biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture. - This study has three separate consent forms: one for adult patients at the NIH Clinical Centre to opt to donate their samples for ongoing research on assay development and studies of molecular pathways; and two for the generation of preclinical models (adult and pediatric). Adult patients at the NIH and participating sites, and also pediatric patients (NIH Clinical Centre only), can opt to donate samples to create preclinical models to study tumour biology and genetics, and to develop new therapies for cancer. - Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
Primary Outcome:
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