Collection of Tissue Samples for Cancer Research

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00900198
First received: May 9, 2009
Last updated: April 2, 2015
Last verified: February 2015
  Purpose

Background:

-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.

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 Center 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, 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.

...


Condition Intervention Phase
Neoplasms
Lymphomas
Procedure: Biopsy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 3000
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)
Intervention Details:
    Procedure: Biopsy
    Tissue samples will be collected for research purposes from non-surgical procedures, such percutaneous biopsies for the sole purpose of obtaining specimens or biological fluids for the protocol.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients who are being evaluated for and or treated at the NIH Clinical Center or at participating sites.

Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.

Age greater than 18 years

EXCLUSION CRITERIA:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900198

Contacts
Contact: Jennifer H Zlott (301) 435-5664 zlottjh@mail.nih.gov
Contact: James H Doroshow, M.D. (301) 496-4291 doroshoj@mail.nih.gov

Locations
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
Yale University Recruiting
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
Indiana University Recruiting
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    kummars@mail.nih.gov   
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
Vanderbilt University Recruiting
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
Canada
Princess Margaret Hospital Recruiting
Toronto, Canada
Sponsors and Collaborators
Investigators
Principal Investigator: James H Doroshow, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00900198     History of Changes
Other Study ID Numbers: 060213, 06-C-0213
Study First Received: May 9, 2009
Last Updated: April 2, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tissue Collection
Biospecimen
Assay Development
Tissue Acquisition
Tissue Biopsies

ClinicalTrials.gov processed this record on April 23, 2015