NCT05167188

Brief Summary

Spontaneous, multicenter, prospective, non-pharmacological study. At the diagnosis of acute or chronic GvHD after HSCT, bone marrow cells will be analysed for MSC content and properties. Bone marrow aspirate will be performed according to usual clinical practise

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

3.4 years

First QC Date

November 24, 2021

Last Update Submit

May 23, 2023

Conditions

Graft Vs Host Disease

Outcome Measures

Primary Outcomes (1)

  • Evaluation of damage generated by acute or chronic GvHD on the MSCs after HSCT

    Through study completion, an average of 1 year

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age6 Months - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients (children and adults) developing acute or chronic GvHD after HSCT

You may qualify if:

  • Patients (children and adults) developing acute or chronic GvHD after HSCT.
  • Age 6 months- month-99 years,
  • Landsky-Karnofsky\> 70%,
  • Acute or chronic GvHD needing further immunosuppressive treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow aspirate

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Franca Fagioli, MD

CONTACT

+39011313franca.fagioli@unito.it

Massimo Berger, MD

CONTACT

+39011313massimoberger@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 22, 2021

Study Start

October 14, 2021

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)