Screening and Genetic Monitoring of Patients With Myelodysplastic Syndromes (MDS) Under Different Treatment Modalities by Cytogenetic Analyses of Circulating CD34+Cells

Myelodysplastic Syndromes (MDS) Clinical Trial

Official title:

Screening and Genetic Monitoring of Patients With MDS Under Different Treatment Modalities by Cytogenetic Analyses of Circulating CD34+Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355913
• Other study ID #: Diagnostik-Studie
• Status: Completed
• Start date: October 2008
• Est. completion date: October 2019

Study information

• Verified date: February 2020
• Source: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In myelodysplastic syndromes (MDS) the knowledge about chromosomal aberrations is important for diagnosis, pathogenesis, prognosis and treatment. Usually, chromosomal anomalies in MDS patients are detected in bone marrow cells by chromosome banding analyses of metaphases. Alternatively or additionally they can be diagnosed by Fluorescence-in-Situ-Hybridization (FISH). The investigators here present a novel method for cytogenetic monitoring of MDS patients from peripheral blood which is representative for the clone size in bone marrow cells. The purpose of this prospective multicenter non-interventional diagnostic study is to detect and to follow chromosomal aberrations from peripheral blood closely, to assess karyotype evolution, to detect rare abnormalities and to correlate the molecular-cytogenetic results with peripheral blood counts, bone marrow morphology and treatment modalities and responses.

Description:

Chromosomal aberrations in myelodysplastic syndromes (MDS) play a major role in diagnostics, pathogenesis, prognosis, and, more recently, in treatment allocations. Chromosomal anomalies can be detected by conventional chromosome banding analyses of bone marrow metaphases and most of them are provable by Fluorescence in situ hybridization (FISH) of circulating CD34+ progenitor cells from peripheral blood. For this prospective multicenter non-interventional diagnostic study sequential FISH analyses are performed on immunomagnetically enriched circulating CD34+ cells from peripheral blood as follows: A "super-panel" with the probes D7/CEP7, EGR1, CEP8, CEP XY, D20, p53, IGH/BCL2, TEL/AML1, RB1, MLL, 1p36/1q25, CSF1R (all Abbott® probes) is used for initial screening, every 12 months during follow-up and in every case of suspected progression. A smaller "standard-panel" with the probes EGR1, D7/CEP7, CEP8, p53, D20, CEP X/Y, TEL/AML1 - plus if necessary an informative probe of the superpanel- was performed for analyses at short intervals every 2 months in the 1st year and every 3 months during the 2nd and 3rd year. Peripheral blood counts are documented once a month, and full blood counts with the number of peripheral blasts are recommended at the time point of each FISH analysis. Bone marrow biopsies are not part of the study, but they are recommended to be performed every 6 to 12 months in the course of the disease. If a bone marrow biopsy is performed, conventional chromosome banding analyses on bone marrow metaphases and, additionally, FISH analyses of enriched CD34+ bone marrow cells and non-enriched bone marrow cells are performed. The results from peripheral blood are correlated with those of conventional banding and FISH analyses performed on bone marrow samples. The aims of this study are to detect acqired chromosomal aberrations in MDS patients from peripheral blood, to follow these anomalies by frequent analyses, to detect rare aberrations and to observe karyotype evolution from peripheral blood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: October 2019
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis (cytomorphologic proof) of primary or secondary myelodysplastic syndrome (MDS) or

• Suspected myelodysplastic syndrome (MDS).

• Age > 18 years

Related Conditions & MeSH terms

• Chromosmal Aberrations
• Cytogenetic Monitoring
• Karyotype Evolution
• Myelodysplastic Syndromes
• Myelodysplastic Syndromes (MDS)
• Preleukemia
• Rare Abnormalities
• Syndrome

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen
Germany	University Hospital Dresden	Dresden
Germany	University Hospital Düsseldorf	Düsseldorf
Germany	Onkologikum	Frankfurt/Main
Germany	University Hospital Frankfurt/Main	Frankfurt/Main
Germany	University Medical Center Göttingen	Goettingen
Germany	Onkologische Kooperation Harz	Goslar
Germany	Group Practice Meyer/Ammon/Müller	Göttingen
Germany	Group Practice Uhle/Müller/Kröning/Jentsch-Ullrich	Magdeburg
Germany	Group Practice Schmidt/Galler/Klapthor	Munich
Germany	Technical University Munich	Munich
Germany	Group Practice Detken/Seraphin	Northeim
Germany	University Hospital Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH	University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening and genetic monitoring of patients with MDS under different treatment modalities by cytogenetic analyses of circulating CD34+cells.	At each timepoint of FISH analysis the percentage of aberrant interphase nuclei is measured of all (at least 200) interphase nuclei counted.	The first FISH analysis is performed at the time of study entry (initial screening) and after that every 2 months in the first year and every 3 months in the second and third year.