DNA Methylation in Allogeneic Hematopoietic Stem Cell Transplantation.

NCT03871296 | Unknown

• 1 other identifier: 151/2018/Sper/AOUBo
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

As a consequence of the impending increase in life expectancy, there is urgent need to adopt life-saving interventions, such as hematopoietic stem cell transplantation, (SCT) in groups of patients that have been regarded as unsuitable for such medical procedures owing to their advanced age. However, a growing body of evidence shows that age per se does not account for a reliable estimation of the capability of an individual to cope with the stressful procedure of SCT and to deal with the cognate adverse effects. Recent literature shows that changes in epigenetic markers (i.e. the extent of methylation) at specific loci of genomic DNA marks the rate of aging and allows for the estimation of the so called "biologic aging." In other words, individuals of the same chronologic age may turn out to be older or younger respect when their biologic age is assessed. This latter is expected to be tightly linked to changes in major homeostatic mechanisms and consequently to be in relationship the chance of successful SCT. The primary objective of the study is the study of DNA in patients undergoing allogeneic haematopoietic stem cell transplantation. DNA will be assessed for the extent of methylation, which will be also in relationship with circulating exogenous DNA (i.e the microbiome).

Conditions

Aging; Stem Cell Transplant Complications

Keywords

DNA-methylation; Allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Study of DNA methylation

  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).

  24 months

Secondary Outcomes (2)

• Study of DNA for the determination of the systemic microbiome..

  24 months

• Transplantation clinical outcomes.

  24 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing allogeneic haematopoietic stem cell transplantation, as part of their normal pth of cure, will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• \- Absence of written informed consent.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Mariarosaria Sessa, MD: collaborator
• Mario Arpinati, MD: collaborator
• Francesco Barbato, MD: collaborator

Study Sites (1)

St.Orsola-Malpighi University Hospital

Bologna, BO, 40138, Italy

RECRUITING

Related Publications (1)

• Bacalini MG, Gentilini D, Boattini A, Giampieri E, Pirazzini C, Giuliani C, Fontanesi E, Scurti M, Remondini D, Capri M, Cocchi G, Ghezzo A, Del Rio A, Luiselli D, Vitale G, Mari D, Castellani G, Fraga M, Di Blasio AM, Salvioli S, Franceschi C, Garagnani P. Identification of a DNA methylation signature in blood cells from persons with Down Syndrome. Aging (Albany NY). 2015 Feb;7(2):82-96. doi: 10.18632/aging.100715.

  PMID: 25701644 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood Urine Feces

Study Officials

• Francesca Bonifazi, MD

  St. Orsola-Malpighi University Hospital, Bologna, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Bonifazi, MD

CONTACT

+390512143799; francesca.bonifazi@unibo.it

Lorenza Di Ianni, DM

CONTACT

+390512143799; lorenzad.ail@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: March 12, 2019
• Study Start: September 10, 2018
• Primary Completion: September 10, 2023
• Study Completion: September 10, 2024
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

IT (1)