Collection of Tissue Samples for Cancer Research

This study is currently recruiting participants.
Verified May 2013 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: March 14, 2014
Last verified: May 2013

May 9, 2009
March 14, 2014
September 2006
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Tissue and fluid collection [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00900198 on ClinicalTrials.gov Archive Site
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Collection of Tissue Samples for Cancer Research
Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)

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.

...

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 obtained 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 tunor biology and genetics, and to develop new therapies for cancer.
  • Patients may remain on study for the duration of their consent.
Observational
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Tissue Analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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  • 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

Both
19 Years and older
No
Contact: Shivaani Kummar, M.D. (301) 435-0517 kummars@mail.nih.gov
United States
 
NCT00900198
060213, 06-C-0213
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National Cancer Institute (NCI)
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Principal Investigator: Shivaani Kummar, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP