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 April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00026663
First received: November 14, 2001
Last updated: May 3, 2014
Last verified: April 2014
  Purpose

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.


Condition
Renal Cell Carcinoma
Lung Carcinoma
Cervical Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Blood, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2000
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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 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.

EXCLUSION CRITERIA:

  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 ClinicalTrials.gov identifier: NCT00026663

Contacts
Contact: Robin R. Eisch, R.N. (301) 402-5958 eischar@mail.nih.gov
Contact: Susan E Bates, M.D. (301) 402-0984 sebates@helix.nih.gov

Locations
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
Investigators
Principal Investigator: Susan E Bates, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00026663     History of Changes
Obsolete Identifiers: NCT00919529
Other Study ID Numbers: 000078, 00-C-0078
Study First Received: November 14, 2001
Last Updated: May 3, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014