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


N/A
19 Years
N/A
Open (Enrolling)
Both
Tissue Analysis

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Trial Information

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

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 biological fluids
for this protocol.

Eligibility:

-Patients who are being evaluated for and/or treated on research protocols at the NIH

Clinical Center.

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.

- 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 blood.

-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. Patients 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 may remain on study for the duration of their consent.

Inclusion Criteria


- INCLUSION CRITERIA:

Patients who are being evaluated for and treated on protocols within the NIH Clinical
Center.

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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Shivaani Kummar, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

060213

NCT ID:

NCT00900198

Start Date:

September 2006

Completion Date:

Related Keywords:

  • Tissue Analysis
  • Tissue Collection
  • Biospecimen
  • Assay Development
  • Tissue Acquisition
  • Tissue Biopsies

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892