Hypercoagulation Screening in Cancer (HYPERCAN)

A.O. Ospedale Papa Giovanni XXIII

Status: Unknown

Conditions: Cancer Patients; Healthy Blood Donors; Moli-sani Subjects

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT02622815

AIRC5xmille - 12237

Details and patient eligibility

About

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.

Enrollment: 16,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

16,000 participants in 3 patient groups

Healthy blood donors

Description:

10,000 highly controlled blood donors in the age range 30-70 years

Moli-sani subjects

Description:

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

Description:

4,000 Patients with breast, lung, and gastrointestinal tumors.