- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04587856
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paola Fazi
- Phone Number: 0670390528
- Email: p.fazi@gimema.it
Study Contact Backup
- Name: Enrico Crea
- Phone Number: 0670390514
- Email: e.crea@gimema.it
Study Locations
-
-
-
Bari, Italy
- Recruiting
- Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
-
Contact:
- Pellegrino Musto
- Email: pellegrino.musto@uniba.it
-
Firenze, Italy
- Recruiting
- Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio
-
Contact:
- Valeria Santini
-
Genova, Italy
- Recruiting
- AOU San Martino-IST-Ematologia 1
-
Contact:
- Carmela Di Grazia
-
Perugia, Italy
- Recruiting
- Sezione di Ematologia - Ospedale S.Maria della Misericordia
-
Contact:
- Cristina Mecucci
-
Roma, Italy
- Recruiting
- Policlinico Tor Vergata
-
Contact:
- Maria Teresa Voso
-
Roma, Italy
- Recruiting
- Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia
-
Contact:
- Massimo Breccia
-
Rozzano, Italy
- Recruiting
- Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia
-
Contact:
- Matteo E Della Porta
- Email: matteo.della_porta@hunimed.eu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Biological evaluation
evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT.
|
bone marrow samples evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CD34+ blast cells modifications
Time Frame: at 24 months
|
Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.
|
at 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDS0620
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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