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Analyses of Human Samples Collected in Clinical Trials

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ClinicalTrials.gov Identifier: NCT00339664
Recruitment Status : Recruiting
First Posted : June 21, 2006
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood, urine, feces, bile, saliva) for research purposes.

The purpose of this study is to conduct further analyses on these existing samples from clinical trials that are being performed outside of, but in collaboration with, the National Cancer Institute.


Condition or disease
Leukemia, Myeloid Neoplasm Metastasis Leukemia, Lymphoid Prostate Cancer

Detailed Description:
Various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) will be collected from cancer patients enrolled on approved clinical trials, in accordance with the local protocol. These trials are being conducted at outside institutions, in collaboration with the National Cancer Institute (NCI) and the samples will be sent to the NCI for pharmacological analysis, involving determination of parent drug and/or metabolite concentrations and subsequent pharmacokinetics and statistical data analysis. This study aims to further characterize the clinical pharmacokinetic behavior of select cancer therapeutics. Future collaborators will be added via the protocol amendment procedure.

Study Design

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute
Study Start Date : July 2, 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. To quantitate drug and/or metabolite concentrations in human bloodsamples [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. To characterize the clinical pharmacological behavior of agents [ Time Frame: Ongoing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer at institutions outside of the intramural NCI are eligible for inclusion, provided that they have consented to pharmacological analysis in the original consent form.

EXCLUSION CRITERIA:

None anticipated at this time.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339664


Contacts
Contact: Julie C Barnes, R.N. (240) 760-6044 barnesjk@mail.nih.gov
Contact: William D Figg, Pharm.D. (240) 760-6179 wdfigg@helix.nih.gov

Locations
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, District of Columbia, United States
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201-1595
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Pili Robert    Not Listed      
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
United States, Minnesota
Mayo Clinic, Rochester Recruiting
Rochester, Minnesota, United States, 55905
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106-2602
United States, Pennsylvania
University of Maryland at Amish Research Clinic, Lancaster Recruiting
Lancaster, Pennsylvania, United States
Abramson Cancer Center, University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Hillman Cancer Center at University of Pittsburg Cancer Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Virginia
McGuire Veterans Administration Medical Center Recruiting
Richmond, Virginia, United States, 23249
Massey Cancer Center, Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: Gelderbloom Hans    Not Listed      
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)
More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00339664     History of Changes
Obsolete Identifiers: NCT00898196
Other Study ID Numbers: 999903242
03-C-N242
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: May 26, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Pharmacokinetics
Quantify
HPLC
LC/MS
Pharmacodynamics

Additional relevant MeSH terms:
Leukemia
Neoplasm Metastasis
Leukemia, Myeloid
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases