Graft vs Host DiseaseALLOCECNCT02064972
CEC Count Changes to Support GvHD Diagnosis.
An observational study of Graft vs Host Disease and Complications of Organ Transplant Stem Cells, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
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 may represent a marker of endothelial damage, we want to evaluate the changes in CEC counts of patients affected by hematological disorders undergoing allo-HSCT, as a function of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graft vs Host Disease, Complications of Organ Transplant Stem Cells, Endothelial Dysfunction
- What is being tested?
- Patients undergoing allo-HSCT, who manifest GvHD.
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, affected by hematologic disorders, undergoing allo-HSCT.
Who may be able to join
- Patients with hematological disorders undergoing allo-HSCT,
- Age 18-65 years.
- Sign of written informed consent form at the time of study entry.
Who cannot join
- No candidates to allo-HSCT.
- Patients under the age of 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Circulating Endothelial Cells (CEC) as a Marker of Endothelial Damage in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT): Correlation With the Occurrence of Graft-versus-Host Disease (GvHD)
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 may represent a marker of endothelial damage, we want to evaluate the changes in CEC counts of patients affected by hematological disorders undergoing allo-HSCT, as a function of endothelial damage. We will enroll 50 patients affected by hematologic disorders undergoing allo-HSCT. Peripheral blood will be drawn before (T1, baseline) and at the end of the conditioning regimen (T2, pre-transplant), upon confirmation of hematopoietic recovery (T3, engraftment) and thereafter at onset of GVHD (GVHD T4) and one week after the start of steroid therapy (T5, post-GvHD). All patients will also be checked for CEC at day + 28. CEC enumeration will be performed by using the CellSearch® System and a flowcytometry procedure.
Through the conduct of this study, we expect to confirm our preliminary results on a larger series of patients, and to evaluate the predictive role of CEC on the occurrence of GvHD and prognostic response to treatment of GvHD. The possibility of early identification of patients who do not respond to traditional treatments of GvHD, and for this reason at a higher risk of morbidity and mortality, may allow greater individualization of the therapeutic program, for example with the introduction as early as possible of alternative treatments. In addition, the identification of patients at higher risk of non-responsiveness to steroid treatment, would allow, through a closer monitoring, the early introduction of additional treatment before the development of resistance/refractoriness to treatment of GvHD.
The present study takes the form of a prospective study. The primary endpoint is the identification and enumeration of CECs in peripheral blood of patients with hematological disorder undergoing allo-HSCT, as a function of endothelial damage. The secondary endpoint is to define the prognostic and predictive value of the changes of CEC counts on the diagnosis of GvHD and response to treatment.
Read the detailed description
The endothelial damage is a characteristic common to several complications of vascular origin that may occur in the course of allo-HSCT (GVHD, IPS, VOD, TMA). The diagnosis of vascular complications represents an interesting challenge, but unfortunately limited by the fact that the markers of endothelial damage are extremely scarce. In particular, the plasmatic dosage of von Willebrand factor, thrombomodulin and adhesion molecules generated results difficult to use for a potential application for routine diagnostics for the high degree of non-specificity and the potential influence on the assay by co-morbid conditions related to the recipient. Much more promising methods appear to be those that are based on the evaluation of microparticles derived from endothelial cells (EMP) or the direct counting of circulating endothelial cells (CEC). Recently, the EMP were assessed by flow cytometry (annexin V-FITC and anti-CD62-PE) in 19 patients undergoing allo-HSCT, showing an increase in patients with acute GvHD grade ≥ I, compared to patients that did not display GvHD. In addition, the evaluation of EMP did not appear to be affected by the radio-chemotherapy conditioning regimen. This method is, however, burdened with a procedural complexity and a certain degree of non-specificity due to the fact that the microparticles can be released by endothelial cells as well as also from platelets, red blood cells and leukocytes.
Currently, the direct counting of the CEC seems to be the most reliable ways to assess the degree of endothelial damage. The finding of elevated numbers of CEC has been shown to reflect the extent of endothelial damage in numerous pathologies of autoimmune nature, but are still preliminary data in the course of allo-HSCT. Woywodt et al. demonstrated in patients with ANCA-positive vasculitis a correlation between the number of CEC and the degree of disease activity and response to treatment. Moreover, the number of CEC correlates, in patients undergoing renal transplantation, with the risk of organ rejection. In the course of allo-HSCT, the same authors have shown a correlation between the number of CEC and endothelial damage induced by radio-chemotherapy conditioning regimen. However, the lack of a standardized method, the use of manual procedures of immunoselection, the lack of consensus on the identification of CEC represent limiting factors for routine application.
The present study takes the form of a prospective study. The primary endpoint is the identification and enumeration of CECs in peripheral blood of patients with hematological disorders undergoing allo-HSCT, as a function of endothelial damage. The secondary endpoint is to define the prognostic and predictive value of CEC counts changes on the diagnosis of GvHD and on the response to treatment.
Peripheral blood (PB) will be drawn before (T1, baseline) and at the end of the conditioning regimen (T2, pre-transplant), upon confirmation of hematopoietic recovery (T3, engraftment) and thereafter at onset of GVHD (GVHD T4) and one week after the start of steroid therapy (T5, post-GvHD) for the control of GvHD. All patients will also be checked for CEC at day + 28.
The peripheral blood for counting CEC will be collected, respectively, in the CellSave Preservative Tube (Veridex, J \& J, USA), containing a preservative for the stabilization of the cells at room temperature, for counting with the CellSearch® System and in CBC tube containing K2EDTA, for counting by flow cytometry.
By the CellSearch® System an event will be classified as CEC when its morphology is consistent with that of a cell and simultaneously shows the following phenotype: CD146+, CD105+, DAPI+ and CD45-. By the flowcytometry procedure, after staining of cells with lyophilized antibodies of the Endo Panel tube (CD146, 7-AAD, CD34, CD309, CD45) 4x106 events in the lympho-monocyte gate will be immediately aquired at flowcytometry.
- Conditions
- Graft vs Host Disease, Complications of Organ Transplant Stem Cells, Endothelial Dysfunction
- Being tested
- Patients undergoing allo-HSCT, who manifest GvHD.
- Keywords
- Graft vs Host Disease, Hematopoietic Stem Cell Transplant, Biological Marker, Circulating Endothelial Cells, Endothelial Dysfunction
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing allo-HSCT, who manifest GvHD.Other
Changes in CEC counts in relation to GvHD ONSET
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing allo-HSCT, who manifest GvHD. | Patients undergoing allo-HSCT, that manifest GvHD. Patients undergoing allo-HSCT will have CEC count performed at the following timepoints: T1 (baseline), T2 (pre-transplant), T3 (engraftment), T4 (GvHD onset) and T5 (post-GvHD). All patients will also be checked for CEC at day + 28. Receives: Other: Patients undergoing allo-HSCT, who manifest GvHD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline (Timepoint 1) in Circulating Endothelial Cell (CEC) count at GvHD onset (Timepoint 4)
CEC count changes will be evaluated between baseline and time of GvHD onset, within day + 100 post-transplant. In our preliminary series of 40 patients GvHD have manifested at a median of 27 days post-transplant (range 15-103).
Measured: Basal (Timepoint 1) versus GvHD onset (Timepoint 4)
Secondary outcomes (3)
Changes from baseline (Timepoint 1) in Circulating Endothelial Cell (CEC) count at time of transplant (Timepoint 2)
CEC count changes will be evaluated between baseline and pre-transplant, which usually is in the range of 5-8 days.
Measured: Basal (Timepoint 1) versus pre-transplant (Timepoint 2)
Changes from baseline (Timepoint 1) in Circulating Endothelial Cell (CEC) count at time of engraftment (Timepoint 3).
CEC count changes will be evaluated between baseline and time of engraftment. In our preliminary series of 40 patients engraftment occurred at a median of 22 days post-transplant (range 14-31).
Measured: Basal (Timepoint 1) versus engraftment (Timepoint 3)
Changes from GvHD onset (Timepoint 3) in Circulating Endothelial Cell (CEC) count at one week after the start of steroid therapy (Timepoint 5).
CEC count changes will be evaluated between GVHD onset and one week after steroid therapy
Measured: GvHD onset (Timepoint 3) versus one week after the start of steroid therapy (Timepoint 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Diagnostics, LLC
- Responsible party
- Principal investigator, Camillo Almici MD, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Camillo Almici, M.D., Principal investigator, Transfusion Medicine, Spedali Civili Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064972
- Sponsor's protocol ID
- NP 1574
- Acronym
- ALLOCEC
- Status last verified
- May 2019
- First submitted
- 13 Feb 2014
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The datasets used and analysed during the current study will be available from the corresponding author on reasonable request after the publication of results.
Publications
Rowand JL, Martin G, Doyle GV, Miller MC, Pierce MS, Connelly MC, Rao C, Terstappen LW. Endothelial cells in peripheral blood of healthy subjects and patients with metastatic carcinomas. Cytometry A. 2007 Feb;71(2):105-13. doi: 10.1002/cyto.a.20364.
PubMed 17226859Woywodt A, Scheer J, Hambach L, Buchholz S, Ganser A, Haller H, Hertenstein B, Haubitz M. Circulating endothelial cells as a marker of endothelial damage in allogeneic hematopoietic stem cell transplantation. Blood. 2004 May 1;103(9):3603-5. doi: 10.1182/blood-2003-10-3479. Epub 2004 Jan 8.
PubMed 14715625Damani S, Bacconi A, Libiger O, Chourasia AH, Serry R, Gollapudi R, Goldberg R, Rapeport K, Haaser S, Topol S, Knowlton S, Bethel K, Kuhn P, Wood M, Carragher B, Schork NJ, Jiang J, Rao C, Connelly M, Fowler VM, Topol EJ. Characterization of circulating endothelial cells in acute myocardial infarction. Sci Transl Med. 2012 Mar 21;4(126):126ra33. doi: 10.1126/scitranslmed.3003451.
PubMed 22440735Chen YB, Cutler CS. Biomarkers for acute GVHD: can we predict the unpredictable? Bone Marrow Transplant. 2013 Jun;48(6):755-60. doi: 10.1038/bmt.2012.143. Epub 2012 Aug 6.
PubMed 22863728Carreras E, Diaz-Ricart M. The role of the endothelium in the short-term complications of hematopoietic SCT. Bone Marrow Transplant. 2011 Dec;46(12):1495-502. doi: 10.1038/bmt.2011.65. Epub 2011 Apr 4.
PubMed 21460864Penack O, Socie G, van den Brink MR. The importance of neovascularization and its inhibition for allogeneic hematopoietic stem cell transplantation. Blood. 2011 Apr 21;117(16):4181-9. doi: 10.1182/blood-2010-10-312934. Epub 2011 Jan 21.
PubMed 21258010Almici C, Skert C, Verardi R, Di Palma A, Bianchetti A, Neva A, Braga S, Malagola M, Turra A, Marini M, Russo D. Changes in circulating endothelial cells count could become a valuable tool in the diagnostic definition of acute graft-versus-host disease. Transplantation. 2014 Oct 15;98(7):706-12. doi: 10.1097/TP.0000000000000385.
PubMed 25119132Lanuti P, Rotta G, Almici C, Avvisati G, Budillon A, Doretto P, Malara N, Marini M, Neva A, Simeone P, Di Gennaro E, Leone A, Falda A, Tozzoli R, Gregorj C, Di Cerbo M, Trunzo V, Mollace V, Marchisio M, Miscia S. Endothelial progenitor cells, defined by the simultaneous surface expression of VEGFR2 and CD133, are not detectable in healthy peripheral and cord blood. Cytometry A. 2016 Mar;89(3):259-70. doi: 10.1002/cyto.a.22730. Epub 2015 Aug 25.
PubMed 26305912Almici C, Neva A, Skert C, Bruno B, Verardi R, Di Palma A, Bianchetti A, Braga S, Piovani G, Cancelli V, Omede P, Baeten K, Rotta G, Russo D, Marini M. Counting circulating endothelial cells in allo-HSCT: an ad hoc designed polychromatic flowcytometry-based panel versus the CellSearch System. Sci Rep. 2019 Jan 14;9(1):87. doi: 10.1038/s41598-018-36442-9.
PubMed 30643152Almici C, Skert C, Bruno B, Bianchetti A, Verardi R, Di Palma A, Neva A, Braga S, Piccinelli G, Piovani G, Malagola M, Bernardi S, Giaccone L, Brunello L, Festuccia M, Baeten K, Russo D, Marini M. Circulating endothelial cell count: a reliable marker of endothelial damage in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2017 Dec;52(12):1637-1642. doi: 10.1038/bmt.2017.194. Epub 2017 Sep 11.
PubMed 28892085
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating Endothelial Cells (CEC) as a Marker of Endothelial Damage in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT): Correlation With the Occurrence of Graft-versus-Host Disease (GvHD)
- ClinicalTrials.gov ID
- NCT02064972
- Acronym / sponsor ID
- ALLOCEC / NP 1574
- Conditions
- Graft vs Host Disease, Complications of Organ Transplant Stem Cells, Endothelial Dysfunction
- Keywords
- Graft vs Host Disease, Hematopoietic Stem Cell Transplant, Biological Marker, Circulating Endothelial Cells, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- Janssen Diagnostics, LLC
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 may represent a marker of endothelial damage, we want to evaluate the changes in CEC counts of patients affected by hematological disorders undergoing allo-HSCT, as a function of endothelial damage. We will enroll 50 patients affected by hematologic disorders undergoing allo-HSCT. Peripheral blood will be drawn before (T1, baseline) and at the end of the conditioning regimen (T2, pre-transplant), upon confirmation of hematopoietic recovery (T3, engraftment) and thereafter at onset of GVHD (GVHD T4) and one week after the start of steroid therapy (T5, post-GvHD). All patients will also be checked for CEC at day + 28. CEC enumeration will be performed by using the CellSearch® System and a flowcytometry procedure.
Through the conduct of this study, we expect to confirm our preliminary results on a larger series of patients, and to evaluate the predictive role of CEC on the occurrence of GvHD and prognostic response to treatment of GvHD. The possibility of early identification of patients who do not respond to traditional treatments of GvHD, and for this reason at a higher risk of morbidity and mortality, may allow greater individualization of the therapeutic program, for example with the introduction as early as possible of alternative treatments. In addition, the identification of patients at higher risk of non-responsiveness to steroid treatment, would allow, through a closer monitoring, the early introduction of additional treatment before the development of resistance/refractoriness to treatment of GvHD.
The present study takes the form of a prospective study. The primary endpoint is the identification and enumeration of CECs in peripheral blood of patients with hematological disorder undergoing allo-HSCT, as a function of endothelial damage. The secondary endpoint is to define the prognostic and predictive value of the changes of CEC counts on the diagnosis of GvHD and response to treatment.
Detailed description
The endothelial damage is a characteristic common to several complications of vascular origin that may occur in the course of allo-HSCT (GVHD, IPS, VOD, TMA). The diagnosis of vascular complications represents an interesting challenge, but unfortunately limited by the fact that the markers of endothelial damage are extremely scarce. In particular, the plasmatic dosage of von Willebrand factor, thrombomodulin and adhesion molecules generated results difficult to use for a potential application for routine diagnostics for the high degree of non-specificity and the potential influence on the assay by co-morbid conditions related to the recipient. Much more promising methods appear to be those that are based on the evaluation of microparticles derived from endothelial cells (EMP) or the direct counting of circulating endothelial cells (CEC). Recently, the EMP were assessed by flow cytometry (annexin V-FITC and anti-CD62-PE) in 19 patients undergoing allo-HSCT, showing an increase in patients with acute GvHD grade ≥ I, compared to patients that did not display GvHD. In addition, the evaluation of EMP did not appear to be affected by the radio-chemotherapy conditioning regimen. This method is, however, burdened with a procedural complexity and a certain degree of non-specificity due to the fact that the microparticles can be released by endothelial cells as well as also from platelets, red blood cells and leukocytes.
Currently, the direct counting of the CEC seems to be the most reliable ways to assess the degree of endothelial damage. The finding of elevated numbers of CEC has been shown to reflect the extent of endothelial damage in numerous pathologies of autoimmune nature, but are still preliminary data in the course of allo-HSCT. Woywodt et al. demonstrated in patients with ANCA-positive vasculitis a correlation between the number of CEC and the degree of disease activity and response to treatment. Moreover, the number of CEC correlates, in patients undergoing renal transplantation, with the risk of organ rejection. In the course of allo-HSCT, the same authors have shown a correlation between the number of CEC and endothelial damage induced by radio-chemotherapy conditioning regimen. However, the lack of a standardized method, the use of manual procedures of immunoselection, the lack of consensus on the identification of CEC represent limiting factors for routine application.
The present study takes the form of a prospective study. The primary endpoint is the identification and enumeration of CECs in peripheral blood of patients with hematological disorders undergoing allo-HSCT, as a function of endothelial damage. The secondary endpoint is to define the prognostic and predictive value of CEC counts changes on the diagnosis of GvHD and on the response to treatment.
Peripheral blood (PB) will be drawn before (T1, baseline) and at the end of the conditioning regimen (T2, pre-transplant), upon confirmation of hematopoietic recovery (T3, engraftment) and thereafter at onset of GVHD (GVHD T4) and one week after the start of steroid therapy (T5, post-GvHD) for the control of GvHD. All patients will also be checked for CEC at day + 28.
The peripheral blood for counting CEC will be collected, respectively, in the CellSave Preservative Tube (Veridex, J \& J, USA), containing a preservative for the stabilization of the cells at room temperature, for counting with the CellSearch® System and in CBC tube containing K2EDTA, for counting by flow cytometry.
By the CellSearch® System an event will be classified as CEC when its morphology is consistent with that of a cell and simultaneously shows the following phenotype: CD146+, CD105+, DAPI+ and CD45-. By the flowcytometry procedure, after staining of cells with lyophilized antibodies of the Endo Panel tube (CD146, 7-AAD, CD34, CD309, CD45) 4x106 events in the lympho-monocyte gate will be immediately aquired at flowcytometry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing allo-HSCT, who manifest GvHD. | – | Other: Patients undergoing allo-HSCT, who manifest GvHD.Patients undergoing allo-HSCT, that manifest GvHD. Patients undergoing allo-HSCT will have CEC count performed at the following timepoints: T1 (baseline), T2 (pre-transplant), T3 (engraftment), T4 (GvHD onset) and T5 (post-GvHD). All patients will also be checked for CEC at day + 28. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, affected by hematologic disorders, undergoing allo-HSCT.
Key inclusion criteria (3 listed)
- Patients with hematological disorders undergoing allo-HSCT,
- Age 18-65 years.
- Sign of written informed consent form at the time of study entry.
Key exclusion criteria (2 listed)
- No candidates to allo-HSCT.
- Patients under the age of 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients undergoing allo-HSCT, who manifest GvHD.Changes in CEC counts in relation to GvHD ONSET | Other | Patients undergoing allo-HSCT, who manifest GvHD. |
Primary outcome
Changes from baseline (Timepoint 1) in Circulating Endothelial Cell (CEC) count at GvHD onset (Timepoint 4)
Time frame: Basal (Timepoint 1) versus GvHD onset (Timepoint 4)
CEC count changes will be evaluated between baseline and time of GvHD onset, within day + 100 post-transplant. In our preliminary series of 40 patients GvHD have manifested at a median of 27 days post-transplant (range 15-103).
3 secondary outcomes
Changes from baseline (Timepoint 1) in Circulating Endothelial Cell (CEC) count at time of transplant (Timepoint 2)
Time frame: Basal (Timepoint 1) versus pre-transplant (Timepoint 2)
Changes from baseline (Timepoint 1) in Circulating Endothelial Cell (CEC) count at time of engraftment (Timepoint 3).
Time frame: Basal (Timepoint 1) versus engraftment (Timepoint 3)
Changes from GvHD onset (Timepoint 3) in Circulating Endothelial Cell (CEC) count at one week after the start of steroid therapy (Timepoint 5).
Time frame: GvHD onset (Timepoint 3) versus one week after the start of steroid therapy (Timepoint 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Background: PubMed 17226859Rowand JL, Martin G, Doyle GV, Miller MC, Pierce MS, Connelly MC, Rao C, Terstappen LW. Endothelial cells in peripheral blood of healthy subjects and patients with metastatic carcinomas. Cytometry A. 2007 Feb;71(2):105-13. doi: 10.1002/cyto.a.20364.
- Background: PubMed 14715625Woywodt A, Scheer J, Hambach L, Buchholz S, Ganser A, Haller H, Hertenstein B, Haubitz M. Circulating endothelial cells as a marker of endothelial damage in allogeneic hematopoietic stem cell transplantation. Blood. 2004 May 1;103(9):3603-5. doi: 10.1182/blood-2003-10-3479. Epub 2004 Jan 8.
- Background: PubMed 22440735Damani S, Bacconi A, Libiger O, Chourasia AH, Serry R, Gollapudi R, Goldberg R, Rapeport K, Haaser S, Topol S, Knowlton S, Bethel K, Kuhn P, Wood M, Carragher B, Schork NJ, Jiang J, Rao C, Connelly M, Fowler VM, Topol EJ. Characterization of circulating endothelial cells in acute myocardial infarction. Sci Transl Med. 2012 Mar 21;4(126):126ra33. doi: 10.1126/scitranslmed.3003451.
- Background: PubMed 22863728Chen YB, Cutler CS. Biomarkers for acute GVHD: can we predict the unpredictable? Bone Marrow Transplant. 2013 Jun;48(6):755-60. doi: 10.1038/bmt.2012.143. Epub 2012 Aug 6.
- Background: PubMed 21460864Carreras E, Diaz-Ricart M. The role of the endothelium in the short-term complications of hematopoietic SCT. Bone Marrow Transplant. 2011 Dec;46(12):1495-502. doi: 10.1038/bmt.2011.65. Epub 2011 Apr 4.
- Background: PubMed 21258010Penack O, Socie G, van den Brink MR. The importance of neovascularization and its inhibition for allogeneic hematopoietic stem cell transplantation. Blood. 2011 Apr 21;117(16):4181-9. doi: 10.1182/blood-2010-10-312934. Epub 2011 Jan 21.
- Background: PubMed 25119132Almici C, Skert C, Verardi R, Di Palma A, Bianchetti A, Neva A, Braga S, Malagola M, Turra A, Marini M, Russo D. Changes in circulating endothelial cells count could become a valuable tool in the diagnostic definition of acute graft-versus-host disease. Transplantation. 2014 Oct 15;98(7):706-12. doi: 10.1097/TP.0000000000000385.
- Background: PubMed 26305912Lanuti P, Rotta G, Almici C, Avvisati G, Budillon A, Doretto P, Malara N, Marini M, Neva A, Simeone P, Di Gennaro E, Leone A, Falda A, Tozzoli R, Gregorj C, Di Cerbo M, Trunzo V, Mollace V, Marchisio M, Miscia S. Endothelial progenitor cells, defined by the simultaneous surface expression of VEGFR2 and CD133, are not detectable in healthy peripheral and cord blood. Cytometry A. 2016 Mar;89(3):259-70. doi: 10.1002/cyto.a.22730. Epub 2015 Aug 25.
- Derived from this study: PubMed 30643152Almici C, Neva A, Skert C, Bruno B, Verardi R, Di Palma A, Bianchetti A, Braga S, Piovani G, Cancelli V, Omede P, Baeten K, Rotta G, Russo D, Marini M. Counting circulating endothelial cells in allo-HSCT: an ad hoc designed polychromatic flowcytometry-based panel versus the CellSearch System. Sci Rep. 2019 Jan 14;9(1):87. doi: 10.1038/s41598-018-36442-9.
- Derived from this study: PubMed 28892085Almici C, Skert C, Bruno B, Bianchetti A, Verardi R, Di Palma A, Neva A, Braga S, Piccinelli G, Piovani G, Malagola M, Bernardi S, Giaccone L, Brunello L, Festuccia M, Baeten K, Russo D, Marini M. Circulating endothelial cell count: a reliable marker of endothelial damage in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2017 Dec;52(12):1637-1642. doi: 10.1038/bmt.2017.194. Epub 2017 Sep 11.
- Individual participant dataSharing planned: Yes. The datasets used and analysed during the current study will be available from the corresponding author on reasonable request after the publication of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camillo Almici, M.D. principal investigator
Transfusion Medicine, Spedali Civili Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft vs Host Disease and Complications of Organ Transplant Stem Cells, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline (Timepoint 1) in Circulating Endothelial Cell (CEC) count at GvHD onset (Timepoint 4) (time frame: Basal (Timepoint 1) versus GvHD onset (Timepoint 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064972, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.