Study Design
In addition to plasma withdrawal at discharge, in the BACS & BAMI studies a second plasma sample was extracted 6-12 months later, on an outpatient basis, with the patients in a stable clinical situation. This paper is a sub-study of the BACS & BAMI studies, and reports the clinical and analytical findings obtained at this second plasma extraction, relating them to subsequent follow-up. Then, the moment of this second plasma extraction is considered to be the baseline visit of this sub-study. At this point, all patients were free of a diagnosis of cancer and even of any symptoms or signs suggesting this diagnosis.
Figure 1 shows the flow chart for patient selection. The baseline visit for this sub-study took place between January 2007 and December 2014. At this moment, clinical variables were recorded and 12-hour fasting venous blood samples were withdrawn. The last follow-up visits took place in June 2016 and included both, a review of the clinical records and an on-site visit or telephone contact.
The primary outcome was the development of a new cancer with histological confirmation, excluding non-melanocytic skin tumors.