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Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2, 2017 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier:
First received: November 14, 2001
Last updated: April 21, 2017
Last verified: February 2, 2017

This study will examine blood, bone marrow, tumor and tissue samples from patients with cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer improve initially with chemotherapy, but then have a disease relapse, after which their tumor no longer responds to treatment. Other patients tumors are drug-resistant from the start. The study will look for "resistance factors" substances in blood and tissues that render tumors resistant to chemotherapy. The findings may provide information needed to develop methods of combating drug resistance.

Patients with cancer who are 18 years or older may be eligible for this study. Participants will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study; additional samples will be obtained periodically during the course of treatment. A small sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor biopsy (removal of a small piece of tumor) for medical reasons or as part of a research treatment protocol. Patients who do not require surgery or biopsy may be asked permission to obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1) withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen; 3) removing a small tumor sample through a needle; or 4) removing the sample with a small incision into or around the tumor. These procedures will be done only if they are of low risk to the patient.

Renal Cell Carcinoma
Lung Carcinoma
Cervical Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Collection of Blood, Fluid, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer or Normal Volunteers

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Obtain specimens to develop assays [ Time Frame: End of study ]

Estimated Enrollment: 100
Study Start Date: February 11, 2000
  Hide Detailed Description

Detailed Description:


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 cancer.

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 patient.

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 samples.

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

    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 indication.
    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.
  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 identifier: NCT00026663

Contact: William D Figg, Pharm.D. (301) 402-3622

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00026663     History of Changes
Obsolete Identifiers: NCT00919529
Other Study ID Numbers: 000078
Study First Received: November 14, 2001
Last Updated: April 21, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Biopsy Samples
Specimen Acquisition
Cancer Cells

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases processed this record on April 28, 2017