Molecular Diagnostic Platform for AML
Developing a Molecular Diagnostic Platform for Personalized Medicine for Acute Myeloid Leukemia
1 other identifier
observational
2,000
1 country
7
Brief Summary
This will be a translational study without any therapeutic intervention, for the purpose of analyzing the diagnostic and molecular results / characterization of adult patients with AML, regardless of the treatment they receive. Newly diagnosed or relapsed/resistant AML patients will be included.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedSeptember 5, 2021
September 1, 2021
3 years
June 17, 2020
September 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of FLT3, NPM1 and CEBPa mutations
Frequency of each of the standard screening panel molecular alterations studied in the AML patients (FLT3, NPM1 and CEBPa), both in newly diagnosed and relapsed/resistant disease.
Baseline
Secondary Outcomes (2)
Frequency of mutations detected by Next Generation Sequency (NGS)
Baseline
Frequency of mutations detected by conventional PCR (FLT3, NPM1 and CEBPa) in every sample (diagnosis, relapse)
Baseline
Study Arms (1)
Acute Myeloid Leukemia (AML)
Newly diagnosed or relapsed/resistant AML
Eligibility Criteria
Patients aged ≥18 years with a diagnosis of AML (new, relapse or refractory).
You may qualify if:
- Have voluntarily given informed consent for the sending and processing of biological specimens, as well as for the analysis and reporting of the results on the mutation status of their AML.
- Age greater than or equal to 18 years.
- Morphological diagnosis of AML or acute leukemia of ambiguous lineage according to WHO criteria at diagnosis, relapse or resistance.
You may not qualify if:
- Inability of the patient or his/her legal representative to understand and voluntarily sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Spain
Hospital Doce de Octubre
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario La Fe
Valencia, Spain
Related Publications (5)
Dohner H, Estey EH, Amadori S, Appelbaum FR, Buchner T, Burnett AK, Dombret H, Fenaux P, Grimwade D, Larson RA, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz MA, Sierra J, Tallman MS, Lowenberg B, Bloomfield CD; European LeukemiaNet. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-74. doi: 10.1182/blood-2009-07-235358. Epub 2009 Oct 30.
PMID: 19880497BACKGROUNDLey TJ, Mardis ER, Ding L, Fulton B, McLellan MD, Chen K, Dooling D, Dunford-Shore BH, McGrath S, Hickenbotham M, Cook L, Abbott R, Larson DE, Koboldt DC, Pohl C, Smith S, Hawkins A, Abbott S, Locke D, Hillier LW, Miner T, Fulton L, Magrini V, Wylie T, Glasscock J, Conyers J, Sander N, Shi X, Osborne JR, Minx P, Gordon D, Chinwalla A, Zhao Y, Ries RE, Payton JE, Westervelt P, Tomasson MH, Watson M, Baty J, Ivanovich J, Heath S, Shannon WD, Nagarajan R, Walter MJ, Link DC, Graubert TA, DiPersio JF, Wilson RK. DNA sequencing of a cytogenetically normal acute myeloid leukaemia genome. Nature. 2008 Nov 6;456(7218):66-72. doi: 10.1038/nature07485.
PMID: 18987736BACKGROUNDMiller CA, Wilson RK, Ley TJ. Genomic landscapes and clonality of de novo AML. N Engl J Med. 2013 Oct 10;369(15):1473. doi: 10.1056/NEJMc1308782. No abstract available.
PMID: 24106950BACKGROUNDJuliusson G, Antunovic P, Derolf A, Lehmann S, Mollgard L, Stockelberg D, Tidefelt U, Wahlin A, Hoglund M. Age and acute myeloid leukemia: real world data on decision to treat and outcomes from the Swedish Acute Leukemia Registry. Blood. 2009 Apr 30;113(18):4179-87. doi: 10.1182/blood-2008-07-172007. Epub 2008 Nov 13.
PMID: 19008455BACKGROUNDDohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, Dombret H, Ebert BL, Fenaux P, Larson RA, Levine RL, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz M, Sierra J, Tallman MS, Tien HF, Wei AH, Lowenberg B, Bloomfield CD. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017 Jan 26;129(4):424-447. doi: 10.1182/blood-2016-08-733196. Epub 2016 Nov 28.
PMID: 27895058BACKGROUND
Biospecimen
Bone marrow and peripheral blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pau Montesinos
Hospital Universitario La Fe
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 25, 2020
Study Start
October 1, 2019
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
September 5, 2021
Record last verified: 2021-09