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

July 7, 2020 updated by: Camillo Almici MD, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • ASST Spedali Civili di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing allo-HSCT for their neoplastic hematologic disorders

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 30 days from allo-HSCT
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
day +100 post allo-HSCT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day +100 post allo-HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborators

University of Turin, Italy
Università degli Studi di Brescia

Investigators

  • Principal Investigator: Camillo Almici, MD, ASST Spedali Civili di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0037975

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Time Frame

after publication of results

IPD Sharing Access Criteria

Request to Principal Investigator

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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