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Myelodysplastic Syndromes (MDS)NCT01355913

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

An observational study of Myelodysplastic Syndromes (MDS) and Chromosmal Aberrations, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 13 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
402 participants
Where
13 sitesGermany
Study dates
Oct 2008to Oct 2019
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: 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.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • University Hospital Aachen

    Aachen

  • University Hospital Dresden

    Dresden

  • University Hospital Düsseldorf

    Düsseldorf

  • Onkologikum

    Frankfurt am Main

  • University Hospital Frankfurt/Main

    Frankfurt am Main

  • Onkologische Kooperation Harz

    Goslar

  • Group Practice Meyer/Ammon/Müller

    Göttingen

  • University Medical Center Göttingen

    Göttingen

  • Group Practice Uhle/Müller/Kröning/Jentsch-Ullrich

    Magdeburg

  • Group Practice Schmidt/Galler/Klapthor

    Munich

  • Technical University Munich

    Munich

  • Group Practice Detken/Seraphin

    Northeim

  • University Hospital Ulm

    Ulm

Other trials in Germany

About this study

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

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.

Read the detailed 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.

Keywords
Myelodysplastic syndromes (MDS), chromosmal aberrations, cytogenetics, Fluorescence in situ hybridization (FISH), CD34+ cells, peripheral blood
Medical subject headings
Myelodysplastic Syndromes

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2011 (estimated)
  2. Study startOct 2008
  3. Primary completionOct 2016
  4. Study completionOct 2019

Resources

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
Time perspective
Prospective
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355913
Sponsor's protocol ID
Diagnostik-Studie
Status last verified
Feb 2020
First submitted
17 May 2011
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26355708

  • 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.

    PubMed 25344522

  • 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.

    PubMed 23623559

Questions about this trial

What is this clinical trial studying?

An observational study of Myelodysplastic Syndromes (MDS) and Chromosmal Aberrations, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 13 sites in Germany.

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 0 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: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Screening and genetic monitoring of patients with MDS under different treatment modalities by cytogenetic analyses of circulating CD34+cells. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01355913, which also lists 3 linked publications.

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 21 Feb 2020.

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