Clinical trial NCT04038827: Origin of CEC in Patients After Allo-HSCT
Official title: Search of Circulating Endothelial Cells of Donor Origin After Allogeneic Hematopoietic Stem Cell Transplantation: Evaluation for Potential Clinically Relevant Implications in the Context of Graft-Versus-Host Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft Versus Host Disease, Acute
Endothelial Dysfunction
Immune Tolerance
Keywords: Circulating Endothelial Cells
Graft versus Host Disease
Neovascularization
Allotransplantation
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Brescia
name: University of Turin, Italy
First posted: 2019-07-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing allo-HSCT for their neoplastic hematologic disorders

Brief summary: We believe that CEC, besides coming from cells shedding from patient vasculature, could partly belong to donor, originating from the cellular graft.

Detailed description: In consideration of the fact that the vascular endothelium has been shown to be a target of GvHD in early stage and that the count of CEC represent a marker of endothelial damage, we want to correlate the presence of donor CEC at engraftment with a putative protective function against GVHD manifestations. We will enroll patients affected by hematologic disorders undergoing allo-HSCT. At time of engraftment and at + 3 months after allo-HSCT, CEC identified and counted by means of the CellSearch system, will be recovered from the counting cartridge and further sorted at the single cell level. STR profile of each single CEC recovered will be performed in order to define host versus donor origin of each CEC analysed.

Through the conduct of this study, we expect to upfront identify patients who will or will not manifest GvHD. This result will allow definitely different clinical approaches: stringent monitoring and early therapeutic intervention, before refractory disease's development, in the formers, while, sparing unnecessarily expensive testing or heavier treatment in the latters.

Eligibility criteria: Inclusion Criteria:

* patients undergoing allo-HSCT for their neoplastic hematologic diseases
* written informed consent
* achievement of hematopoietic recovery from aplasia post-allo-HSCT
* predictable life expectancy \> 6 months

Exclusion Criteria:

* presence of active malignant hematologic disease at time of allo-HSCT

Primary outcomes:
measure: Presence of D-CEC at time of engraftment in patients undergoing allo-HSCT
timeFrame: Within 30 days from allo-HSCT
measure: Correlate presence/absence of D-CEC with GVHD manifestations
timeFrame: day +100 post allo-HSCT
Secondary outcomes:
measure: Presence of donor CEC embedded in the endothelial layer of patients microvasculature at late timepoint after allo-HSCT
timeFrame: day +100 post allo-HSCT
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Camillo Almici, MD
role: PRINCIPAL_INVESTIGATOR
References:
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