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OpenTrials
Completed

NCT Number: NCT04038827

Origin of CEC in Patients After Allo-HSCT

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-CEC counting

Diagnostic Test

By means of preliminary bulk separation step with the CellSearch system, single CEC will be sorted

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Collaborators

  • University of Turin, Italy
  • Università degli Studi di Brescia

Registry information

Official study 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

Acronym: DCEC-PIANO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2019
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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