An observational study in Healthy Blood Donors, Moli-sani Subjects and Cancer Patients, sponsored by A.O. Ospedale Papa Giovanni XXIII. Status unknown at 8 sites in Italy. Per ClinicalTrials.gov, last updated 2018-10-29.
Sponsored by A.O. Ospedale Papa Giovanni XXIII · Observational
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.
75 studies on the registry are indexed under Thrombophilia; 16 are open to participants now.
This study's planned enrollment of 16,000 is above the median of 106 across 50 observational studies indexed under Thrombophilia.
Browse Thrombophilia studies →A.O. Ospedale Papa Giovanni XXIII is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Blood donors (age range 30-70 years), who agree to participate, fulfill a specific questionnaire on their lifestyle and donate venous blood samples at the enrollment into the study, and after 6-12 months.
The parental cohort of the Moli-sani project included 24,325 subjects (>35 years) from the Molise region. Blood samples have been collected and stored in the Moli-sani biobank available to this project.
Cancer patients of both genders (>18 years) with new diagnosis of non small cell lung cancer, gastrointestinal tumors, and breast cancer are enrolled at different recruiting sites. Blood samples are collected at the enrollment and at specific time points during follow-up without interfering with clinical management.
Blood donors_
Inclusion Criteria:
Exclusion Criteria: (considering 10-15 days from blood sampling)
Cancer patients_
Inclusion Criteria:
Exclusion Criteria:
10,000 highly controlled blood donors in the age range 30-70 years
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).
4,000 Patients with breast, lung, and gastrointestinal tumors.
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)
Time frame: 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.
Time frame: within 5 years from the date of the enrollment
Incidence of Cancer progression among enrolled cancer patients
Identification of cancer patients with evidence of cancer progression derived from review of clinical records.
Time frame: within 5 years from the date of the enrollment
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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A.O. Ospedale Papa Giovanni XXIII