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Hypercoagulation Screening in Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02622815
Acronym
HYPERCAN
Enrollment
16000
Registered
2015-12-07
Start date
2012-04-30
Completion date
2020-01-31
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Patients, Healthy Blood Donors, Moli-sani Subjects

Keywords

Hypercoagulation, Thrombosis, Cancer Risk Assessment, Cancer Prognosis

Brief 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.

Interventions

None listed

Sponsors

Associazione Italiana per la Ricerca sul Cancro
CollaboratorOTHER
Istituto Neurologico Mediterraneo Neuromed S. R. L
CollaboratorOTHER
Fondazione Humanitas per la Ricerca
CollaboratorOTHER
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
CollaboratorOTHER
ASL Roma 1
CollaboratorUNKNOWN
Istituti Ospedalieri Bergamaschi Srl
CollaboratorOTHER
ASST Bergamo Ovest
CollaboratorOTHER
Istituti Tumori Giovanni Paolo II
CollaboratorNETWORK
A.O. Ospedale Papa Giovanni XXIII
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of blood donors with a diagnosis of cancerwithin 5 years from the date of the enrollmentSamples 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)
Incidence of Thrombotic events among enrolled cancer patientswithin 5 years from the date of the enrollmentIdentification of cancer patients with evidence of thrombotic event derived from review of clinical records.

Secondary

MeasureTime frameDescription
Incidence of Cancer progression among enrolled cancer patientswithin 5 years from the date of the enrollmentIdentification of cancer patients with evidence of cancer progression derived from review of clinical records.

Countries

Italy

Contacts

Primary ContactAnna Falanga, MD
annafalanga@icthic.com+39-035.267.8597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026