Detecting Cancer Signals on Breath

The Project

LuCID was an international multi-centre prospective study designed to evaluate the diagnostic accuracy (sensitivity and specificity) of a breath test for lung cancer. We recruited over 2000 participants from 17 sites across Europe, each providing multiple breath samples, detailed medical histories, demography and diagnostic data. All participants were followed up for 2 years. Volatiles from breath were collected onto sorbent material in tubes and analysed via GC-MS in Owlstone's Breath Biopsy Laboratory.

Study Website ClinicalTrials.gov

Best Practices

• Code as Documentation: I wrote scripts to automatically generate documentation about the Electronic Data Capture (EDC) configuration, to ensure the documentation always accurately described the EDC.
• Test Driven Development: I wrote User Acceptance Test (UAT) scripts for mid-study changes prior to implementing the changes, to validate that the test script accurately targeted the error
• Tracking configuration in Git:I logged EDC specifications in Git for gold-standard source control and to ensure changes between multiple branches could be tracked and reconciled

My Contributions

I was responsible for clinical data management:

• the design of the Electronic Data Capture (EDC), including 25 Case Report Forms configured in OpenClinica
• configuration of bespoke off-line Electronic Data Capture with integration with the Breath Collection Software
• design and implementation of data flows to ensure robust reconciliation of data across systems (2 EDCs + lab samples)
• data validation of data entered in EDCs
• ran and recorded User Acceptance Testing
• reconciliation of data discrepancies
• thorough documentation of the study design
• reporting on recruitment progress
• data extraction for interim and final analyses
• database lock
• dataset archiving
• ensuring full compliance with GxP, GDPR, 21 CFR Part-11