Hypercoagulation Screening in Cancer

Last updated: October 26, 2018
Sponsor: A.O. Ospedale Papa Giovanni XXIII
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Blood Clots

Treatment

N/A

Clinical Study ID

NCT02622815
AIRC5xmille - 12237
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Blood donors_ Inclusion Criteria:

  • good health

  • signed informed consent.

Exclusion

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 chemotherapyregimen;

  • 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.

Study Design

Total Participants: 16000
Study Start date:
April 01, 2012
Estimated Completion Date:
January 31, 2020

Connect with a study center

  • Istituti Ospedalieri Bergamaschi S.r.l. - Policlinico San Marco

    Osio Sotto, Bergamo 24040
    Italy

    Active - Recruiting

  • A.S.S.T. Bergamo Ovest

    Treviglio, Bergamo 24047
    Italy

    Active - Recruiting

  • I.R.C.C.S. Istituto Neurologico Mediterraneo NEUROMED

    Pozzilli, Isernia 86077
    Italy

    Site Not Available

  • Fondazione Humanitas per la Ricerca

    Rozzano, Milan 20089
    Italy

    Active - Recruiting

  • Papa Giovanni XXIII Hospital - Oncology Unit

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Papa Giovanni XXIII Hospital - S.I.M.T.

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133
    Italy

    Active - Recruiting

  • ASL Roma 1 - ACO San Filippo Neri & San Giovanni Maria Addolorata Hospital

    Rome, 00135
    Italy

    Active - Recruiting

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