Leukemia, MyeloidNCT00339664
Analyses of Human Samples Collected in Clinical Trials
An observational study of Leukemia, Myeloid and Neoplasm Metastasis, run by National Cancer Institute (NCI) at 17 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Leukemia, Myeloid, Neoplasm Metastasis, Leukemia, Lymphoid
- How many people
- 2,579 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 2 Jul 2003to 26 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer@@@
Who may be able to join
- 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.
Who cannot join
- None anticipated at this time.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States15 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201-1595
Johns Hopkins Medical Center
Baltimore, Maryland, 21231
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Case Western Reserve University
Cleveland, Ohio, 44106-2602
University of Maryland at Amish Research Clinic, Lancaster
Lancaster, Pennsylvania
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Hillman Cancer Center at University of Pittsburg Cancer Institute
Pittsburgh, Pennsylvania, 15261
McGuire Veterans Administration Medical Center
Richmond, Virginia, 23249
Massey Cancer Center, Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Childrens National Medical Center
Washington D.C., District of Columbia
Netherlands2 sites
Leiden University Medical Center
Leiden
Erasmus Medical Center
Rotterdam
About this study
Official title: 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.
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.
- Keywords
- Pharmacokinetics, Quantify, HPLC, LC/MS, Pharmacodynamics
- Medical subject headings
- Leukemia, Myeloid, Neoplasm Metastasis, Leukemia, Lymphoid, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/ patients | Patients on approved clinical trials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug and/or metabolite concentration
To quantitate drug and/or metabolite concentrations in human blood samples
Measured: Ongoing
Secondary outcomes (1)
Pharmacological behavior of agents
To characterize the clinical pharmacological behavior of agents
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start2 Jul 2003
- Primary completion17 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, MyeloidStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,579 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William D Figg, Pharm.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339664
- Sponsor's protocol ID
- 999903242
- Other IDs
- 03-C-N242
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2006
- Last updated
- 30 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute
- ClinicalTrials.gov ID
- NCT00339664
- Acronym / sponsor ID
- 999903242
- Keywords
- Pharmacokinetics, Quantify, HPLC, LC/MS, Pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,579 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 2 Jul 2003 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/ patients | – | –Patients on approved clinical trials |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer@@@
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None anticipated at this time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug and/or metabolite concentration
Time frame: Ongoing
To quantitate drug and/or metabolite concentrations in human blood samples
1 secondary outcome
Pharmacological behavior of agents
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William D Figg, Pharm.D. principal investigator
National Cancer Institute (NCI)
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid and Neoplasm Metastasis, run by National Cancer Institute (NCI) at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug and/or metabolite concentration (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.