Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
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Purpose
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.
| Condition |
|---|
|
Acute Myeloid Leukemia (AML) Acute Promyelocytic Leukemia (APL) Refractory Anemia With Excess of Blasts (RAEB) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler |
- Acceptance Criteria [ Time Frame: Sample taken at initial visit with no follow up (Day 1) ] [ Designated as safety issue: No ]The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.
Biospecimen Retention: Samples With DNA
RNA from bone marrow samples will be retained.
| Estimated Enrollment: | 545 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Martin Tallman, MD 212-639-3842 TallmanM@mskcc.org | |
| Principal Investigator: Martin Tallman, MD | |
| Sub-Investigator: Ross Levine, MD | |
| United States, Ohio | |
| James Cancer Hospital | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Janelle Solt 614-247-1944 janelle.solt@osumc.edu | |
| Principal Investigator: Guido Marcucci, MD | |
| Germany | |
| University Hospital Ulm | Recruiting |
| Ulm, Germany, 89081 | |
| Contact: Lars Bullinger, MD +49 731 50045703 lars.bullinger@uniklinik-ulm.de | |
| Principal Investigator: Hartmut Doehner, MD | |
| Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, Netherlands, 3015 AA | |
| Contact: Emelie Hacker +31 010 7034546 e.hacker@erasmusmc.nl | |
| Principal Investigator: Bob Lowenberg, MD | |
| United Kingdom | |
| Cardiff University | Recruiting |
| Cardiff, Heath Park, United Kingdom, CF144XN | |
| Contact: Amanda Gilkes +44 29 20744522 gilkes@cardiff.ac.uk | |
| Principal Investigator: Alan Burnett, MD | |
| Principal Investigator: | Martin Tallman, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Guido Marcucci, MD | James Cancer Hospital |
| Principal Investigator: | Alan Burnett, MD | Cardiff University- School of Medicine |
| Principal Investigator: | Hartmut Doehner, MD | University Hospital Ulm |
| Principal Investigator: | Bob Lowenberg, MD | Erasmus Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Skyline Diagnostics BV |
| ClinicalTrials.gov Identifier: | NCT01463410 History of Changes |
| Other Study ID Numbers: | PROT-015 |
| Study First Received: | October 28, 2011 |
| Last Updated: | August 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Chromosome Aberrations Chromosome Disorders Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Promyelocytic, Acute |
Hematologic Diseases Myelodysplastic Syndromes Bone Marrow Diseases Pathologic Processes Congenital Abnormalities Genetic Diseases, Inborn Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013