Hypercoagulation Screening in Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Hypercoagulation Screening as Innovative Tool for Risk Assessment, Early Diagnosis and Prognosis in Cancer

Conditions
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Healthy Blood Donors, Moli-sani Subjects, Cancer Patients

Participation Criteria
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Eligibility Criteria
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Blood donors_ Inclusion Criteria: good health signed informed consent. Exclusion Criteria: (considering 10-15 days from blood sampling) inflammations/infections/fever; recent vaccinations; recent surgery; anticoagulant therapy. Cancer patients_ Inclusion Criteria: with life expectation higher than 3 months; patients with breast, lung or gastrointestinal tumors candidated for chemotherapy regimen; ECOG PS 0-2; adeguate bone marrow and renal function; signed informed consent. Exclusion Criteria: acute medical illness; terminal conditions or life expectancy less than 3 months; under low molecular weight heparin at therapeutic dosage.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy blood donors<br>10,000 highly controlled blood donors in the age range 30-70 years | |
| Moli-sani subjects<br>A sample of 1,000 tumor cases have been identified so far and samples from these participants will be analyzed compared to 1,000 controls from randomly extracted from the Moli-sani cohort (parent cohort). | |
| Cancer patients<br>4,000 Patients with breast, lung, and gastrointestinal tumors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blood donors with a diagnosis of cancer | Samples collected from identified participants with cancer diagnosis will be assessed to determine the hypercoagulation profile (ratio for laboratory analysis cancer case : healthy control from same cohort = 1:3, matched for age and gender) | within 5 years from the date of the enrollment | 
| Incidence of Thrombotic events among enrolled cancer patients | Identification of cancer patients with evidence of thrombotic event derived from review of clinical records. | within 5 years from the date of the enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cancer progression among enrolled cancer patients | Identification of cancer patients with evidence of cancer progression derived from review of clinical records. | within 5 years from the date of the enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypercoagulation, Thrombosis, Cancer Risk Assessment, Cancer Prognosis