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blood samples were withdrawn.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.