Collection of Tissue Samples for Cancer Research

Official Title

Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)

Summary:

Background: -Patients who are being evaluated or are on research protocols at the NIH Clinical Centre or at participating sites will be entered onto this screening and tissue procurement protocol for collection of tissue specimens. Objectives: -To obtain samples for research purposes from tests performed for clinical indications or research indications on other research protocols, and to obtain samples for research purposes from non-surgical procedures, performed for the sole purpose of obtaining samples for this protocol. Eligibility: -Patients who are being evaluated for and/or treated on protocols within the NIH Clinical Centre or at participating sites. Design: - 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 that a given patient is enrolled in. - These procedures may include, but are not limited to, laboratory tests on blood, CSF, urine or other specimens; and needle biopsies. - Given the risks associated with any procedure, the procedure will be discussed in detail with the patients, including the side effects, prior to obtaining a separate consent for each procedure. - 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), and bone marrow. These specimens will be stored without patient identifiers and used to perform only those research studies that are outlined in this protocol. Patients can opt to donate samples to create preclinical models to study tumour biology and genetics, and to develop new therapies for cancer. Once a patient is taken off study, he or she may be re-consented and enrolled at a later time to obtain another research specimen as part of this protocol.

Trial Description

Background: -Patients who are being evaluated and/or treated at the NIH Clinical Centre or participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Objectives:

  • To obtain samples for research purposes from tests performed for clinical & research indications on other research protocols.
  • 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: -Patients who are being evaluated for and/or treated for cancer at the NIH Clinical Centre or at participating sites. Design:
  • This is a multicentre tissue procurement protocol with NCI as the coordinating centre.
  • 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 that a given patient is enrolled in.
  • 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.
  • Given the risks associated with any invasive procedure, such as tumour biopsy, the procedure will be discussed in detail with the patients, 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.
  • 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 identifier and used to perform only those research studies that are outlined in this protocol.
  • This study has two separate consent forms at the NIH: patients at the NIH Clinical Centre can opt to donate their samples for ongoing research on assay development and studying pathways. In addition, patients can opt to donate samples to create preclinical models to study tumour biology and genetics, and to develop new therapies for cancer. Patients enrolled onto this protocol in participating sites will be donating specimens (tumour, blood) for the creation of 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society