2014TP001 - Assessing the Biology of the Injured Lung - Version 1

NCT05978011 | Completed

• 1 other identifier: 2014TP001
• Study Type: observational
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief Summary

Respiratory diseases are very common and are the third leading cause of death in England. As such, there is strong interest in understanding how respiratory disease occurs. This study intends to understand the changes that occur within diseased/injured lungs obtained from humans. The end goal of this will be to create new drugs to help treat these disorders. Diseased lungs will be obtained from patients receiving a lung transplant. Lungs will either be placed onto a heart-lung machine, or surgically cut in order to create a model of the lung that can be used experimentally in the laboratory. Using a heart-lung machine, lungs can be maintained outside of the human body for a maximum of 12 hours, allowing the direct assessment of the organ. Using this procedure, we aim to understand the processes that occur within a disease, as well as during repair. Using the model of the lung, we will look at how the body's immune system interacts within a diseased lung.

Conditions

Respiratory Diseases

Outcome Measures

Primary Outcomes (1)

• To identify the mechanisms that occur during lung inflammation, injury and repair and the contribution of immune cells to these processes.

  Cytokines and chemokines within lungs will be assessed to determine inflammatory profiles. This will be done using luminex arrays that allow quantification of a range of immunologic molecules in bronchoalveolar lavage and perfusate samples. This will provide a broad overview of the prevailing local tissue environment. We will also assess this following immunomodulation as this may be significantly altered by the presence of immunomodulatory therapeutics.

  Prior to lung transplantation.

Secondary Outcomes (5)

• Characterise the migration and functional profile of immune cells within the inflamed/damaged lung.

  Prior to lung transplantation

• Assess the effectiveness of therapeutic agents that can repair lung damage.

  Prior to lung transplantation

• Trial therapeutic agents that can modulate the effect of immune cells in response to lung tissue injury.

  Prior to lung transplantation

• Identify new therapeutic targets/agents that can reduce the incidence/severity of inflammatory respiratory conditions.

  Prior to lung transplantation

• Cut sections of the lung to culture in an in vitro lung model to assess the effect of various different mechanisms of injury on the function and characteristics of immune cells.

  Prior to lung transplantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Respiratory disorders - lung transplantation

You may qualify if:

• Patients must be able to provide informed consent
• Patients must be aged between 18-80 years of age

You may not qualify if:

• Patients under 16 or over 70 years of age

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 7, 2023
• Study Start: August 29, 2014
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: August 7, 2023

Record last verified: 2023-07