NCT01355913

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
completed

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, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

8 years

First QC Date

May 17, 2011

Last Update Submit

February 20, 2020

Conditions

Myelodysplastic Syndromes (MDS)Chromosmal AberrationsKaryotype EvolutionRare AbnormalitiesCytogenetic Monitoring

Keywords

Myelodysplastic syndromes (MDS)chromosmal aberrationscytogeneticsFluorescence in situ hybridization (FISH)CD34+ cellsperipheral blood

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

20 ml of peripheral blood (pb) of a MDS patient are enriched by immunomagnetic cell sorting (by MACS® system). A FISH analysis is performed on these CD34+ cells according to product protocols using the FISH probe panels described above. The percentage of aberrant interphase nuclei (IN) is measured related to all (at least 200) IN counted. FISH analyses are performed every 2 months in the 1st and every 3 months in the 2nd and 3rd year of follow-up by the same method using the standard panel and, if necessary, an informative probe of the super panel. Pb counts are documented once a month, and full blood counts with peripheral blasts are recommended at the time point of each FISH analysis. Bone marrow (bm) biopsies are not part of the study, but they are recommended to be performed every 6 to 12 months. If a bm biopsy is performed, conventional chromosome banding analyses on bm metaphases and FISH analyses of enriched CD34+ and non-enriched bm cells are performed.

You may qualify if:

  • Clinical diagnosis (cytomorphologic proof) of primary or secondary myelodysplastic syndrome (MDS) or
  • Suspected myelodysplastic syndrome (MDS).
  • Age \> 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University Hospital Aachen

Aachen, Germany

Location

University Hospital Dresden

Dresden, Germany

Location

University Hospital Düsseldorf

Düsseldorf, Germany

Location

Onkologikum

Frankfurt am Main, Germany

Location

University Hospital Frankfurt/Main

Frankfurt am Main, Germany

Location

Onkologische Kooperation Harz

Goslar, Germany

Location

Group Practice Meyer/Ammon/Müller

Göttingen, Germany

Location

University Medical Center Göttingen

Göttingen, Germany

Location

Group Practice Uhle/Müller/Kröning/Jentsch-Ullrich

Magdeburg, Germany

Location

Group Practice Schmidt/Galler/Klapthor

Munich, Germany

Location

Technical University Munich

Munich, Germany

Location

Group Practice Detken/Seraphin

Northeim, Germany

Location

University Hospital Ulm

Ulm, Germany

Location

Related Publications (3)

  • Braulke F, Muller-Thomas C, Gotze K, Platzbecker U, Germing U, Hofmann WK, Giagounidis AA, Lubbert M, Greenberg PL, Bennett JM, Sole F, Slovak ML, Ohyashiki K, Le Beau MM, Tuchler H, Pfeilstocker M, Hildebrandt B, Aul C, Stauder R, Valent P, Fonatsch C, Bacher U, Trumper L, Haase D, Schanz J. Frequency of del(12p) is commonly underestimated in myelodysplastic syndromes: Results from a German diagnostic study in comparison with an international control group. Genes Chromosomes Cancer. 2015 Dec;54(12):809-17. doi: 10.1002/gcc.22292. Epub 2015 Sep 10.

    PMID: 26355708DERIVED

  • Braulke F, Platzbecker U, Muller-Thomas C, Gotze K, Germing U, Brummendorf TH, Nolte F, Hofmann WK, Giagounidis AA, Lubbert M, Greenberg PL, Bennett JM, Sole F, Mallo M, Slovak ML, Ohyashiki K, Le Beau MM, Tuchler H, Pfeilstocker M, Nosslinger T, Hildebrandt B, Shirneshan K, Aul C, Stauder R, Sperr WR, Valent P, Fonatsch C, Trumper L, Haase D, Schanz J. Validation of cytogenetic risk groups according to International Prognostic Scoring Systems by peripheral blood CD34+FISH: results from a German diagnostic study in comparison with an international control group. Haematologica. 2015 Feb;100(2):205-13. doi: 10.3324/haematol.2014.110452. Epub 2014 Oct 24.

    PMID: 25344522DERIVED

  • Braulke F, Jung K, Schanz J, Gotze K, Muller-Thomas C, Platzbecker U, Germing U, Brummendorf TH, Bug G, Ottmann O, Giagounidis AA, Stadler M, Hofmann WK, Schafhausen P, Lubbert M, Schlenk RF, Blau IW, Ganster C, Pfeiffer S, Shirneshan K, Metz M, Detken S, Seraphin J, Jentsch-Ullrich K, Bohme A, Schmidt B, Trumper L, Haase D. Molecular cytogenetic monitoring from CD34+ peripheral blood cells in myelodysplastic syndromes: first results from a prospective multicenter German diagnostic study. Leuk Res. 2013 Aug;37(8):900-6. doi: 10.1016/j.leukres.2013.03.019. Epub 2013 Apr 25.

    PMID: 23623559DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Detlef Haase, MD, Prof.

    University Medical Center Göttingen

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 18, 2011

Study Start

October 1, 2008

Primary Completion

October 1, 2016

Study Completion

October 1, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

DE(13)