Hypercoagulation Screening in Cancer

Summary

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.

Conditions

• Healthy Blood Donors
• Moli-sani Subjects
• Cancer Patients

Sponsors & Collaborators

• Associazione Italiana per la Ricerca sul Cancro

  collaborator OTHER

• Istituto Neurologico Mediterraneo Neuromed S. R. L

  collaborator OTHER

• Fondazione Humanitas per la Ricerca

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  collaborator OTHER

• ASL Roma 1

  collaborator UNKNOWN

• Istituti Ospedalieri Bergamaschi Srl

  collaborator OTHER

• ASST Bergamo Ovest

  collaborator OTHER

• Istituti Tumori Giovanni Paolo II

  collaborator NETWORK

• A.O. Ospedale Papa Giovanni XXIII

  lead OTHER

Principal Investigators

• Anna Falanga, MD · A.O. Papa Giovanni XXIII - Recruiting

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2019-12-31

Completion

2020-01-31

Countries

• Italy

Study Locations