Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bone marrow withdrawal.
- Who it may be relevant to
- Registry conditions: Myelodysplastic Syndromes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome
Overview
This is a biological study for adult MDS patients who undergo HSCT procedure. 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 to study genomic and transcriptomic changes.
Detailed description
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.
Interventions
- Other bone marrow withdrawal
bone marrow samples evaluation
Primary outcome measures
- CD34+ blast cells modifications [Time frame: at 24 months]
Eligibility criteria
Inclusion criteria
- Diagnosis of MDS according to 2016 WHO criteria
- Aged 18y or older
- Patients who will receive allogeneic stem cell transplantation (HSCT)
- Signed written informed consent according to ICH/EU/GCP and national local laws
Exclusion criteria
- Second HSCT procedure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Italy · 7 centers
- Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto — Bari
- Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio — Florence
- AOU San Martino-IST-Ematologia 1 — Genova
- Sezione di Ematologia - Ospedale S.Maria della Misericordia — Perugia
- Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia — Roma
- Policlinico Tor Vergata — Roma
- Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia — Rozzano
Identifiers
NCT: NCT04587856 · MDS0620