BB Quick- Study to Create a QC Panel in Patients with AATD
Research type
Research Study
Full title
Study to create a Quality Control Panel for the development of a new in vitro diagnostic device to be used in patients tested for Alpha-1-Antitrypsin deficiency (AATD)
IRAS ID
192825
Contact name
Ravindran Mahadeva
Contact email
Sponsor organisation
Grifols Deutschland GmbH
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
The aim of this study to establish a quality control (QC) panel in order to create a new in vitro (meaning in a laboratory, such as in a test tube) device, intended for the screening of AATD.
AATD stands for Aplha-1 antitrypsin deficiency and is a chronic, hereditary condition that is often not diagnosed until it is in its later stages, during the fourth decade of life. The deficiency is associated with the increased risk of diseases such as emphysema (a lung disease) and liver cirrhosis (liver damage). Whilst the condition itself is very rare, AATD is one of the most common metabolic disorders that individuals are born with (known as congenital).
Individuals are often misdiagnosed as having other respiratory illnesses, such as Chronic Obstructive Pulmonary Disorder (COPD), before they are correctly diagnosed with AATD. The purpose of developing a new testing method is to help individuals obtain a diagnosis more quickly.
The study will be run from two sites, one in the UK and one in Germany. Blood samples will be collected from patients and then shipped to a laboratory in Dundee, UK. Patients who agree to participate will be required to attend one appointment, and will be required to give one blood sample. There will be no other procedures. The study is planning to enrol 100 male and female patients across the study sites.
To be eligible for the study, patients must have a diagnosis of lung disease/COPD and confirmation on whether or not AATD is the cause of this lung disease/COPD.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0487
Date of REC Opinion
9 Mar 2016
REC opinion
Further Information Favourable Opinion