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Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer or Normal Volunteers

18 Years
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Trial Information

Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer or Normal Volunteers


Ongoing research in the Experimental and Molecular Therapeutics Sections, NCI, requires the
availability of blood, serum, tumor, hair follicle and tissue samples from patients with

Resistance is the underlying cause of treatment failure, and may present as acquired or
intrinsic drug resistance. Patients with cancer frequently present with
chemotherapy-responsive disease, and undergo tumor response, only to eventually experience
relapse, at which time the tumor may be refractory to further treatment. This is termed
acquired drug resistance; while intrinsic resistance implies a cancer that is refractory
from the outset. Diverse mechanisms of drug resistance have been described and are often
dependent upon the particular drug under study.


To obtain blood, serum, tumor, hair follicle or normal tissue samples that would allow
development of assays for use in subsequent clinical trials


Patients with a prior diagnosis of malignancy, with advanced or refractory cancer will be
evaluated in the Medical Oncology Clinic, NCI.

Blood samples or hair follicle samples may be collected at the initial visit, and at follow
up visits.

Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal
fluid, or by excisional biopsy, providing the tumor is accessible with a minimal risk to the

Patients may be on, or in the process of being evaluated for a research protocol.

Patients may receive treatment on the standard care protocol.

Normal volunteers may enroll in the study for collection of blood or hair follicle samples.


Acquired samples will be recorded in the computerized data bank currently existing in the
Molecular Therapeutics Section. No germline testing will be performed on any of the samples
collected. Tests will be pilot studies relating to the Section's work on the biology of drug
resistance and cell survival in cancer. If any research tests are considered to be
themselves of more than minimal risk to the patient, separate permission will be requested
from the IRB to perform that test, and a new consent will be obtained.

Examples of the types of studies to be performed with biopsies will be drug resistance gene
expression assays, with the goal of demonstrating the utility of the assay in patient

Evaluation of methods to detect drug resistance proteins and genes will be explored,
including Northern blot, immunoblot, polymerase chain reaction assay, and RNA in situ
hybridization. With whole blood, we may evaluate the presence of dye transport in an ex vivo
assay, for example, using inhibitors of ABCG2. Evidence of drug accumulation or DNA damage
may be sought in patient mononuclear cells or in hair follicle samples.

Inclusion Criteria


1. Patients 18 years of age and older are eligible.

2. Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to
this protocol.

3. Patients with malignancy are eligible.

4. Patients requiring a surgical procedure for any medical indication can be
included on study.

5. Patients requiring biopsy or any procedure for any medical indication can be
included on study.

6. Patients not requiring biopsy for a medical indication can be included on the
study solely for the purpose of obtaining research samples, including blood,
pleural fluid, or peritoneal fluid, or biopsy samples, providing the biopsy or
aspiration procedure is of minimal risk, i.e. fine needle aspirate, bone marrow
aspirate, or excisional biopsy. No radiology tests will be used in the procedure
to collect a sample that would not be otherwise used for an appropriate medical

7. Normal volunteers 18 years of age and older are eligible to enroll. Normal
volunteers must be willing to sign informed consent and must be willing to
provide samples to be used for research.


1. Pregnant individuals will not be eligible due to potential risks to the fetus
associated with radiologic procedures required for biopsy.

2. Children will not be eligible because of potential risks from complications due to
procedures involved in obtaining the biopsies.

3. Normal volunteers with a history of a clotting disorder may not enroll.

Type of Study:


Study Design:


Principal Investigator

Susan E Bates, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Neoplasm
  • Resistance
  • Malignant
  • Biopsy Samples
  • Specimen Acquisition
  • Cancer Cells
  • Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892