Individual Molecular MRD Monitoring for MDS Patients After Allo-SCT
NCT ID: NCT02872662
Last Updated: 2018-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2016-08-31
2019-08-31
Brief Summary
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Detailed Description
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Screening of mutations In collaboration with Department for clinical genetics, Uppsala, an initial screening of mutations will be performed using the commercial TrueSight© sequencing panel which includes 54 genes recurrently mutated in myeloid diseases. Based on the mutations identified, PCR-primers for all patient-specific mutations will be designed. Patients without any mutation will be excluded from the study. The mutational screen is performed as soon as a patient is being identified as a potential candidate for allogeneic stem cell transplantation (SCT) and evaluated for most optimal pre-SCT treatment. The patient is included in the study before the bone marrow sampling preceding SCT. In case a mutational screen has not been performed before pre-SCT MDS treatment, a mutational screen from the diagnostic national biobank sample (peripheral blood) can be performed.
MRD surveillance After the transplantation, peripheral blood samples will be collected once monthly; and bone marrow samples will be collected at month 1, 3, 6 after SCT followed by sampling every third month until relapse or death. The samples are sent to Biobanking and Molecular Resource Infrastructure of Sweden (bbmri) who will extract DNA and store the samples. By using the highly sensitive digital-PCR method the investigators will determine the size of the different clones at the different time points. In addition to biobanking of DNA, bbmri will collect and vital froze mononuclear cells (MNCs) to be used for experimental studies.
Statistics Landmark analyses will be performed at different time points after SCT, using presence of MRDs as a risk factor included in a multivariate analysis. Furthermore, the investigators will calculate sensitivity, specificity and predictive value for MRDs in relation to relapse. For each specific mutation, with high enough frequency in the cohort, the investigators will define cut-off values of the MRD where relapse is impending.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. One or more mutations identified
3. Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Nordic MDS Group
NETWORK
Responsible Party
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Principal Investigators
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Eva Hellström-Lindberg, Prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Department of Hematology, Aarhus University Hospital
Aarhus, , Denmark
Department of Hematology, Rigshospitalet Univsersity Hospital
Copenhagen, , Denmark
Department of Medcine, Haukeland University Hospital
Bergen, , Norway
Department of Hematology, Rikshospitalet University Hospital
Oslo, , Norway
Department of Hematology and Coagulation, Sahlgrenska University hospital
Gothenburg, , Sweden
Department of Hematology, Lund University Hospital
Lund, , Sweden
Department of Hematology, Karolinska University Hospital
Stockholm, , Sweden
Department of Hematology, Akademiska University Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Lars Kjeldsen
Role: primary
Astrid Olsnes Kittang
Role: primary
Eva Hellstrom-Lindberg
Role: primary
References
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Tobiasson M, Pandzic T, Illman J, Nilsson L, Westrom S, Ejerblad E, Olesen G, Bjorklund A, Olsnes Kittang A, Werlenius O, Lorentz F, Rasmussen B, Cammenga J, Weber D, Lindholm C, Wiggh J, Dimitriou M, Moen AE, Yip Lundstrom L, von Bahr L, Baltzer-Sollander K, Jadersten M, Kytola S, Walldin G, Ljungman P, Groenbaek K, Mielke S, Jacobsen SEW, Ebeling F, Cavelier L, Smidstrup Friis L, Dybedal I, Hellstrom-Lindberg E. Patient-Specific Measurable Residual Disease Markers Predict Outcome in Patients With Myelodysplastic Syndrome and Related Diseases After Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2024 Apr 20;42(12):1378-1390. doi: 10.1200/JCO.23.01159. Epub 2024 Jan 17.
Other Identifiers
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NMDSG14B
Identifier Type: -
Identifier Source: org_study_id
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