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CompletedNCT00339664Updated Mar 30, 2020

Analyses of Human Samples Collected in Clinical Trials

An observational study in Leukemia, Myeloid, Neoplasm Metastasis and Leukemia, Lymphoid, sponsored by National Cancer Institute (NCI). Completed at 17 sites in 2 countries. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
2,579
Ages
Up to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leukemia, Myeloid
  • Neoplasm Metastasis
  • Leukemia, Lymphoid
  • Prostate Cancer

Keywords

  • Pharmacokinetics
  • Quantify
  • HPLC
  • LC/MS
  • Pharmacodynamics
03

In context

Leukemia, Myeloid

2,432 studies on the registry are indexed under Leukemia, Myeloid; 205 are open to participants now.

This study's enrollment of 2,579 is above the median of 117 across 290 observational studies indexed under Leukemia, Myeloid.

Browse Leukemia, Myeloid studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer@@@

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

EXCLUSION CRITERIA:

None anticipated at this time.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
2,579 participants (actual)

Groups and cohorts

  • 1/ patients

    Patients on approved clinical trials

06

What researchers measure

Primary outcomes

  1. Drug and/or metabolite concentration

    To quantitate drug and/or metabolite concentrations in human blood samples

    Time frame: Ongoing

Secondary outcomes

  1. Pharmacological behavior of agents

    To characterize the clinical pharmacological behavior of agents

    Time frame: Ongoing

07

Study locations

17 sites
  • Childrens National Medical Center
    Washington D.C., District of Columbia, United States
  • H. Lee Moffitt Cancer Center & Research Institute
    Tampa, Florida 33612, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • University of Maryland, Baltimore
    Baltimore, Maryland 21201-1595, United States
  • Johns Hopkins Medical Center
    Baltimore, Maryland 21231, United States
  • Sidney Kimmel Comprehensive Cancer Center
    Baltimore, Maryland 21231, United States
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
  • Mayo Clinic, Rochester
    Rochester, Minnesota 55905, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106-2602, United States
  • University of Maryland at Amish Research Clinic, Lancaster
    Lancaster, Pennsylvania, United States
  • Abramson Cancer Center, University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Hillman Cancer Center at University of Pittsburg Cancer Institute
    Pittsburgh, Pennsylvania 15261, United States
  • Hollings Cancer Center at Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • McGuire Veterans Administration Medical Center
    Richmond, Virginia 23249, United States
  • Massey Cancer Center, Virginia Commonwealth University
    Richmond, Virginia 23298, United States
  • Leiden University Medical Center
    Leiden, Netherlands
  • Erasmus Medical Center
    Rotterdam, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00339664
Responsible party
Sponsor
First posted
Jun 21, 2006
Start date
Jul 2, 2003
Primary completion
Mar 17, 2020
Completion
Mar 26, 2020
Last update
Mar 30, 2020

Study contacts

William D Figg, Pharm.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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