Analyses of Human Samples Collected in Clinical Trials

March 27, 2020 updated by: National Cancer Institute (NCI)

Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2579

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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@@@

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1/ patients
Patients on approved clinical trials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug and/or metabolite concentration
Time Frame: Ongoing
To quantitate drug and/or metabolite concentrations in human blood samples
Ongoing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacological behavior of agents
Time Frame: Ongoing
To characterize the clinical pharmacological behavior of agents
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2003

Primary Completion (Actual)

March 17, 2020

Study Completion (Actual)

March 26, 2020

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999903242
  • 03-C-N242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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