Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients
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|ClinicalTrials.gov Identifier: NCT04587856|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : May 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Other: bone marrow withdrawal||Not Applicable|
This is a biological study for adult MDS patients who undergo HSCT procedure.The research is focused on the study of biological mechanisms of disease relapse after HSCT in MDS to provide the rationale to develop pre-emptive strategies in patients with high risk of transplant failure.
Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence.
CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant by using Single-cell sequencing.
To study genomic and transcriptomic changes in CD34+ blast cells at disease relapse after HSCT will be used TARGET-seq in parallel with unbiased whole-transcriptome analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome|
|Actual Study Start Date :||February 12, 2021|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT.
Other: bone marrow withdrawal
bone marrow samples evaluation
- CD34+ blast cells modifications [ Time Frame: at 24 months ]Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587856
|Contact: Paola Faziemail@example.com|
|Contact: Enrico Creafirstname.lastname@example.org|
|Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto||Recruiting|
|Contact: Pellegrino Musto email@example.com|
|Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia||Recruiting|
|Contact: Matteo E Della Porta firstname.lastname@example.org|