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Clinical Trials/NCT02622815
NCT02622815
Unknown
Not Applicable

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

A.O. Ospedale Papa Giovanni XXIII8 sites in 1 country16,000 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Blood Donors
Sponsor
A.O. Ospedale Papa Giovanni XXIII
Enrollment
16000
Locations
8
Primary Endpoint
Number of blood donors with a diagnosis of cancer
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
January 2020
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
A.O. Ospedale Papa Giovanni XXIII
Responsible Party
Principal Investigator
Principal Investigator

ANNA FALANGA

Director of the Division of Immunohematology and Transfusion Medicine

Papa Giovanni XXIII Hospital

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Number of blood donors with a diagnosis of cancer

Time Frame: within 5 years from the date of the enrollment

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)

Incidence of Thrombotic events among enrolled cancer patients

Time Frame: within 5 years from the date of the enrollment

Identification of cancer patients with evidence of thrombotic event derived from review of clinical records.

Secondary Outcomes

  • Incidence of Cancer progression among enrolled cancer patients(within 5 years from the date of the enrollment)

Study Sites (8)

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