Clinical Trials Directory

Trials / Completed

CompletedNCT01735526

Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Hematopoietic Stem-cell Transplantation

Changes in Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Allogeneic Versus Autologous Hematopoietic Stem-cell Transplantation

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Early after allogeneic hematopoietic stem-cell transplantation (allo-HSCT), reductions of absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently detected even in the absence of overt idiopathic pneumonia syndrome (IPS). It can be hypothesized that these changes might be due to an occult intersitial lung disease associated with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens or any combination of these. To test this hypothesis, we will simultaneously measure the lung diffusing capacity for nitric oxide (DLNO) and DLCO and estimate the changes of membrane diffusing capacity (DM) and pulmonary capillary volume (Vc) by the DLNO/DLCO ratio. As we hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT) recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with those of subjects undergoing allo-HSCT.

Detailed description

In allogeneic hematopoietic stem-cell transplantation (allo-HSCT) recipients, early reductions of absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently detected even in the absence of overt idiopathic pneumonia syndrome (IPS)\[PMID: 22221781\]. Two months after allo-HSCT, we have recently shown an increase in lung tissue density determined by quantitative CT scan \[PMID: 22898044\]. It can be hypothesized that these parenchymal changes might be due to an occult intersitial lung disease associated with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens or any combination of these \[PMID: 21531955\]. To test this hypothesis, we will simultaneously measure the lung diffusing capacity for nitric oxide (DLNO) and DLCO. Assuming, for clinical purposes, that the reaction rate of NO with blood hemoglobin is infinite so that DLNO = DMNO = DMCO\*alpha (alpha = NO/CO diffusivity ratio), as to partition the effect of HSCT on membrane diffusing capacity (DM) and pulmonary capillary volume (Vc) we will use the DLNO/DLCO ratio \[PMID:16478855\]. As we hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT) recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with those of subjects undergoing allo-HSCT.

Conditions

Timeline

Start date
2012-10-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2012-11-28
Last updated
2014-09-23

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01735526. Inclusion in this directory is not an endorsement.