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Origin of CEC in Patients After Allo-HSCT (DCEC-PIANO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038827
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
Università degli Studi di Brescia
University of Turin, Italy
Information provided by (Responsible Party):
Camillo Almici MD, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

Condition or disease Intervention/treatment
Graft Versus Host Disease, Acute Endothelial Dysfunction Immune Tolerance Diagnostic Test: D-CEC counting

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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : August 27, 2019
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: D-CEC counting
    By means of preliminary bulk separation step with the CellSearch system, single CEC will be sorted


Primary Outcome Measures :
  1. Presence of D-CEC at time of engraftment in patients undergoing allo-HSCT [ Time Frame: Within 30 days from allo-HSCT ]
    Single CEC will be isolated and STR profile determined

  2. Correlate presence/absence of D-CEC with GVHD manifestations [ Time Frame: day +100 post allo-HSCT ]
    D-CEC presence will be correlated with GVHD onset


Secondary Outcome Measures :
  1. Presence of donor CEC embedded in the endothelial layer of patients microvasculature at late timepoint after allo-HSCT [ Time Frame: day +100 post allo-HSCT ]
    CISH analysis will be performed on tissue biopsies at 3 months post-transplant


Biospecimen Retention:   Samples With DNA
DNA will be obtained from each single CEC


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing allo-HSCT for their neoplastic hematologic disorders
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

Information from the National Library of Medicine

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): NCT04038827


Locations
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Italy
ASST Spedali Civili di Brescia
Brescia, Italy, 25123
Sponsors and Collaborators
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Università degli Studi di Brescia
University of Turin, Italy
Investigators
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Principal Investigator: Camillo Almici, MD ASST Spedali Civili di Brescia
Publications:

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Responsible Party: Camillo Almici MD, Director of the Stem Cells Lab, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT04038827    
Other Study ID Numbers: 0037975
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The datasets generated and analyzed during the current study will be available from the corresponding author on reasonable request after publication of results
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: after publication of results
Access Criteria: Request to Principal Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camillo Almici MD, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia:
Circulating Endothelial Cells
Graft versus Host Disease
Neovascularization
Allotransplantation
Additional relevant MeSH terms:
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Graft vs Host Disease
Acute Disease
Immune System Diseases
Disease Attributes
Pathologic Processes