Genetics of Bleomycin Lung Damage (version 1.0)
Research type
Research Study
Full title
Genome wide association study of genetic variants associated with Bleomycin induced pneumonitis
IRAS ID
165445
Contact name
David Church
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Treatment of testicular cancer represents one of the key successes of modern medicine. Whereas previously, disease that had disseminated was universally fatal, it is now curable in over 95% of cases. Treatment consists of a combination of chemotherapy drugs, each with its own side effects. One of these drugs, Bleomycin, is associated with an uncommon (2-3% of treated patients) but potentially serious, and sometimes fatal, side-effect of lung damage. This is referred to as as Bleomycin Induced Pneumonitis (BIP).
We plan to recruit men from cancer centres across the United Kingdom who have developed BIP as a result of their testicular cancer treatment. Men with a prior diagnosis of BIP will be identified via follow-up clinics and clinical databases. Similarly, men who develop BIP during treatment at participating centres will also be potential candidates for recruitment. Both groups of patients will be invited to participate.
A single blood sample (2 x EDTA tubes per patient; approximately 20-30mL in total) will be sent to our laboratory in Oxford where we will extract DNA and perform genotyping (analysis of genetic variants). Samples will be anonymised and stored in a secure environment.
The study will last until we have recruited approximately 200 participants. We predict that this number is required to detect genetic variants that predispose to BIP in both a preliminary cohort (approximately 150 participants) and also a separate replication cohort (approximately 50 participants). We anticipate this will take 3 years. Patients who participate will answer a questionnaire and provide a single blood sample (2 x EDTA tubes per patient; approximately 20-30mL in total). No additional tests or clinic visits are required.
REC name
North of Scotland Research Ethics Committee 2
REC reference
17/NS/0067
Date of REC Opinion
17 Jul 2017
REC opinion
Favourable Opinion