Cancer Patients Clinical Trial
Official title:
Hypercoagulation Screening as Innovative Tool for Risk Assessment, Early Diagnosis and Prognosis in Cancer
There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has
the capacity to activate the hemostatic system and this leads to an increased thrombotic risk
in cancer patients. Even in the absence of clinical manifestations, cancer patients are
commonly characterized by hemostatic abnormalities, recognized only by laboratory testing,
which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly
reported to be associated with tumor progression and poor prognosis in various carcinomas. On
the other hand, thrombotic event can represent the first signal of the presence of an occult
tumor. These findings suggest that the coagulant pathway might play a role in the preclinical
phase of cancer. The investigators hypothesize that a persistent, subclinical activation of
the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis,
but also to tumor formation and spreading. A major problem in primary cancer prevention is
the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing
prospective Italian multicenter study organized around two tightly-interconnected research
programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer risk
prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors
of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region;
and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis
(or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes
(i.e. overall survival, progression free survival in metastatic cancer, disease free survival
in limited disease) in cancer patients with different types of solid tumors (i.e. breast,
lung and gastrointestinal cancers).
Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful
for anticipation of cancer diagnosis. In addition, the results of this study might help to
evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the
disease extension.
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