Skip to main content
OpenTrials
Completed

NCT Number: NCT01735526

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • baseline spirometry, lung volumes, and DLCO of the subjects included in the analysis must be within the predicted normal range
  • all patients must be in stable clinical conditions at the time of study

Exclusion criteria

  • a history of bronchial asthma, chronic obstructive pulmonary disease, or other significant respiratory disease

Treatment and study plan

Primary outcomes

  1. Changes in DLNO/DLCO ratio after allo- versus autologous HSCT

    Time frame: Before and 2-6 months after HSCT

Secondary outcomes

  1. Changes in lung tissue density after allo- versus autologous HSCT

    Time frame: Before and 2-6 months after HSCT

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Other

Registry information

Official study title

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

Acronym: DLNO/DLCO

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2012
Registry last updated
Sep 23, 2014

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.

Published trials that share one or more normalized conditions with this study.