DNA Methylation in Allogeneic Hematopoietic Stem Cell Transplantation. (MET_SCT_2018)
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ClinicalTrials.gov Identifier: NCT03871296 |
Recruitment Status :
Recruiting
First Posted : March 12, 2019
Last Update Posted : May 30, 2023
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Condition or disease |
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Aging Stem Cell Transplant Complications |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | DNA Methylation in Allogeneic Hematopoietic Stem Cell Transplantation (MET_SCT_2018). |
Actual Study Start Date : | September 10, 2018 |
Estimated Primary Completion Date : | September 10, 2023 |
Estimated Study Completion Date : | September 10, 2024 |
- Study of DNA methylation [ Time Frame: 24 months ]Study of DNA in samples of patients undergoing allogeneic haematopoietic stem cell transplantation. In particular, DNA will be extracted from leukocytes and plasma extracellular nanovesicles. DNA will be assessed for the extent of methylation, which will be also in relationship with circulating exogenous DNA (i.e the microbiome).
- Study of DNA for the determination of the systemic microbiome.. [ Time Frame: 24 months ]Study of DNA in urine and faeces samples of the same subjects to describe further elements of the systemic microbiome - namely the urinary virome and the intestinal microbiome-.
- Transplantation clinical outcomes. [ Time Frame: 24 months ]Correlation of circulating epigenome and systemic microbiome with clinical outcomes (overall survival, GVHD, incidence of infections) and comorbidity index (HCT-CI).
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients aged ≥ 18.
- Patients with haematological disease undergoing allogeneic haematopoietic stem cell transplantation at "Seràgnoli" Hematology Institute, S. Orsola-Malpighi Hospital.
- Patients who consent to participate after signing written informed consent.
Exclusion Criteria:
- Absence of written informed consent.
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): NCT03871296
Contact: Francesca Bonifazi, MD | +390512143799 | francesca.bonifazi@unibo.it | |
Contact: Lorenza Di Ianni, DM | +390512143799 | lorenzad.ail@aosp.bo.it |
Italy | |
St.Orsola-Malpighi University Hospital | Recruiting |
Bologna, BO, Italy, 40138 | |
Contact: Francesca Bonifazi, MD +390512143799 francesca.bonifazi@unibo.it | |
Contact: Lorenza Di Ianni, DM +390512143799 lorenzad.ail@aosp.bo.it |
Principal Investigator: | Francesca Bonifazi, MD | St. Orsola-Malpighi University Hospital, Bologna, Italy |
Responsible Party: | Francesca Bonifazi, MD, Principal Investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna |
ClinicalTrials.gov Identifier: | NCT03871296 |
Other Study ID Numbers: |
151/2018/Sper/AOUBo |
First Posted: | March 12, 2019 Key Record Dates |
Last Update Posted: | May 30, 2023 |
Last Verified: | May 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
DNA-methylation Allogeneic stem cell transplantation |