Acute Myeloid Leukemia (AML)NCT01463410
Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
An observational study of Acute Myeloid Leukemia (AML) and Acute Promyelocytic Leukemia (APL), run by Skyline Diagnostics BV at 5 sites in 4 countries.
Trial summary
This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Acute Promyelocytic Leukemia (APL), Refractory Anemia With Excess of Blasts (RAEB)
- How many people
- 264 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Oct 2011to Mar 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bone marrow samples will be used in the study only from AML,APL or RAEB subjects. Written informed consent by subjects will be obtained for use of their bone marrow samples in this study. Each site will follow their own bone marrow aspiration procedure.
Who may be able to join
- Subjects with a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- ≥ 18 years
- Written informed consent
Who cannot join
- Subjects without a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- < 18 years
- Without written informed consent
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
James Cancer Hospital
Columbus, Ohio, 43210
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the United States of America.
The objective is to demonstrate the positive and negative percent agreement of each marker by comparing AMLProfiler results from multiple clinical participating sites with data generated using a laboratory developed bi-directional sequencing method generated at the molecular diagnostic reference lab.
The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or APL specific chromosomal aberrations (specific recurrent translocations and inversions), as well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of patients with Acute Myeloid Leukemia.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Promyelocytic Leukemia (APL), Refractory Anemia With Excess of Blasts (RAEB)
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Promyelocytic, Acute, Anemia, Refractory, with Excess of Blasts
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance Criteria
The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.
Measured: Sample taken at initial visit with no follow up (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionMar 2013
Why it stopped: The required number of banked samples could not be met due to limited availability. There is no realistic possibility to complete the study succesfully.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- 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
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skyline Diagnostics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Illumina, Inc.
- Responsible party
- Sponsor
- Investigators
- Martin Tallman, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterGuido Marcucci, MD, Principal investigator, James Cancer HospitalAlan Burnett, MD, Principal investigator, Cardiff University- School of MedicineHartmut Doehner, MD, Principal investigator, University Hospital UlmBob Lowenberg, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463410
- Sponsor's protocol ID
- PROT-015
- Status last verified
- May 2013
- First submitted
- 28 Oct 2011
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
- ClinicalTrials.gov ID
- NCT01463410
- Acronym / sponsor ID
- PROT-015
- Conditions
- Acute Myeloid Leukemia (AML), Acute Promyelocytic Leukemia (APL), Refractory Anemia With Excess of Blasts (RAEB)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The required number of banked samples could not be met due to limited availability. There is no realistic possibility to complete the study succesfully.
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Skyline Diagnostics BVIndustry (pharma, biotech, devices)
- Collaborators
- Illumina, Inc.
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Nov 2011 (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.
This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the United States of America.
The objective is to demonstrate the positive and negative percent agreement of each marker by comparing AMLProfiler results from multiple clinical participating sites with data generated using a laboratory developed bi-directional sequencing method generated at the molecular diagnostic reference lab.
The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or APL specific chromosomal aberrations (specific recurrent translocations and inversions), as well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of patients with Acute Myeloid Leukemia.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bone marrow samples will be used in the study only from AML,APL or RAEB subjects. Written informed consent by subjects will be obtained for use of their bone marrow samples in this study. Each site will follow their own bone marrow aspiration procedure.
Key inclusion criteria (3 listed)
- Subjects with a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- ≥ 18 years
- Written informed consent
Key exclusion criteria (3 listed)
- Subjects without a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- < 18 years
- Without written informed consent
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
Acceptance Criteria
Time frame: Sample taken at initial visit with no follow up (Day 1)
The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.
Results and safety
The study was stopped early (reason given: The required number of banked samples could not be met due to limited availability. There is no realistic possibility to complete the study succesfully.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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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.
Martin Tallman, MD principal investigator
Memorial Sloan Kettering Cancer Center
Guido Marcucci, MD principal investigator
James Cancer Hospital
Alan Burnett, MD principal investigator
Cardiff University- School of Medicine
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML) and Acute Promyelocytic Leukemia (APL), run by Skyline Diagnostics BV at 5 sites in 4 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany, Netherlands, United Kingdom. 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 was stopped early (reason given: The required number of banked samples could not be met due to limited availability. There is no realistic possibility to complete the study succesfully.). Results are not available in the source record.
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?
Acceptance Criteria (time frame: Sample taken at initial visit with no follow up (Day 1)). 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 29 May 2013.