Collection of Tissue Samples for Cancer Research
-Patients who are being evaluated or are on research protocols at the NIH Clinical Center or at participating sites will be entered onto this screening and tissue procurement protocol for collection of tissue specimens.
-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.
-Patients who are being evaluated for and/or treated on protocols within the NIH Clinical Center or at participating sites.
- 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, tumor 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 tumor 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)|
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900198
|Contact: Jennifer H Zlott||(301) firstname.lastname@example.org|
|Contact: James H Doroshow, M.D.||(301) email@example.com|
|United States, California|
|University of California, Davis||Recruiting|
|Davis, California, United States, 95616|
|United States, Colorado|
|University of Colorado||Recruiting|
|Denver, Colorado, United States, 80220-3706|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06510-8005|
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202-5262|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Shivaani Kummar, M.D. 301-496-4916 firstname.lastname@example.org|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109-0624|
|United States, Missouri|
|Washington University, St. Louis||Recruiting|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106-2602|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|United States, Virginia|
|Univ. of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Princess Margaret Hospital||Recruiting|
|Principal Investigator:||James H Doroshow, M.D.||National Cancer Institute (NCI)|