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Collection of Tissue Samples for Cancer Research

This study is currently recruiting participants.
See Contacts and Locations
Verified June 16, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00900198
First received: May 9, 2009
Last updated: June 30, 2017
Last verified: June 16, 2017
  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: No masking
Primary Purpose: Other
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) ( National Cancer Institute (NCI) ):

Estimated Enrollment: 4000
Study Start Date: September 18, 2006
Estimated Study Completion Date: December 31, 2019
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.
Detailed Description:

Background:

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

Design:

  • This is a multicenter tissue procurement protocol with NCI as the coordinating center.
  • 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 tumor 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, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor 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 Center 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 tumor biology and genetics, and to develop new therapies for cancer. Patients enrolled onto this protocol in participating sites will be donating specimens (tumor, blood) for the creation of preclinical models to study tumor biology and genetics, and to develop new therapies for cancer.
  • Patients may remain on study for the duration of their consent.
  Eligibility

Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Patients who are being evaluated and or treated for cancer 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:

  • Patients with invasive fungal infections
  • Patients with active and/or uncontrolled infections or who are still recovering from an infection:

    • Actively febrile patients with uncertain etiology of febrile episode
    • All antibiotics should be completed at least 1 week (7 days) prior to collection
    • No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
  • Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV without documented resolution. Testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated.
  • Tumor tissue or blood collections from patients with benign tumors including desmoid tumors, carcinoma in situ, or ongoing complete disease response (CR).
  • Blood only collections from patients with partial or stable disease response

    • Blood will not be collected from patients whose disease demonstrates ongoing partial response or with ongoing (i.e., prolonged) stable disease given the poor rate of model generation from such samples.
    • Blood will not be collected from patients between doses within a single treatment cycle
  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: Nancy Moore, R.N. (301) 402-5640 nancy.moore@nih.gov
Contact: James H Doroshow, M.D. (301) 496-4291 doroshoj@mail.nih.gov

Locations
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95616
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80220-3706
United States, Indiana
Indiana University Perdue 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, Missouri
Washington University, St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States
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
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 28104
Canada
Princess Margaret Hospital Recruiting
Toronto, Canada
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: James H Doroshow, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00900198     History of Changes
Other Study ID Numbers: 060213
06-C-0213
Study First Received: May 9, 2009
Last Updated: June 30, 2017

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

ClinicalTrials.gov processed this record on July 21, 2017